| Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human ServicesSeptember 16, 2010
2010-DAL-WL-15
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Guy L. Mayer, President/CFO
Ascension Orthopedics, Incorporated
8700 Cameron Road, Suite 100
Austin, Texas 78754
Dear Mr. Mayer:
During an inspection of your firm located in Austin, Texas on March 3, 2010 through March 8, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Interphalangeal (PIP) Trials, accessories for Ascension PIP Interphalangeal Joint Implants. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your Interphalangeal (PIP) Trial devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and Title 21 Code of Federal Regulations (C.F.R.) Part 806 - Reports of Corrections and Removals regulation.
We received a response from David C. Furr, Sr. VP QA/RA/CA dated May 7, 2010, concerning FDA's recall classification memo for recall Z-1524-2010, Ascension PyroCarbon PIP Total Joint - Trials. We address this response below, in relation to the noted violation. These deviations include, but are not limited to, the following:
1. Failure to submit a written report to FDA of any correction and removal of a device to reduce a risk to health within 10 working days of initiating such correction or removal, as required by 21 CFR 806.10(a)(1). For example:
Your firm initiated an investigation for the metal trials that were oversized relative to the corresponding implants, as identified through customer complaints. Your firm received thirteen complaints for oversized trials, including a report of proximal phalangeal bone fracture when the trial was inserted that required a suture. You identified the root cause for the oversized trials as incomplete design verification of the size and dimension of the trials and, in response, you re-designed the trials to more closely match the implants. You instructed customers on June 17, 2009, to return the old trials for replacement with the redesigned trials. You notified customers that the older trials for the Ascension PyroCarbon PIP were obsolete and would be replaced with redesigned trials. Your firm recalled and replaced 64 sets of trials from the market. You classified this action as a Market Withdrawal and did not notify FDA of this recall. FDA notified you on May 5, 2010 that your action is a Class II recall, a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
We reviewed your response and conclude that it is incomplete in that the response did not document whether corrective action was taken or would be taken to assure your firm's compliance with the Corrections and Removals regulation.
Our inspection revealed that your Proximal Interphalangeal (PIP) - Trial devices are also misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation.
We received a response from David C. Furr, Sr. VP QA/RA/CA dated March 15, 2010, concerning our investigator's observation noted on the Form FDA 483, List of Inspectional Observations, that was issued to Mr. Furr. We address this response below, in relation to each of the noted violations. These deviations include, but are not limited to, the following:
2. Failure to submit a report to FDA no later than 30 calendar days of receiving information that reasonably suggests that your marketed devices may have caused or contributed to a death or serious injury, as required by 21 C.F.R. 803.50(a)(1). For example:
Complaint 2008-038 contains documentation that the bone fractured after insertion of the Trial, and that the surgeon was required to use a suture on the bone, which is information your firm became aware of on May 21, 2008. The fracture of the bone represents the injury sustained with the use of the oversized trial. The application of a suture represents the surgical intervention required to preclude permanent impairment or damage to a body structure. This information reasonably suggests that your device may have caused or contributed to a reportable serious injury. After the inspection, you submitted a Serious Injury MedWatch report for Complaint 2008-038 on March 8, 2010. This MDR was submitted approximately 620 days late.
We reviewed your response and conclude that it is inadequate because you did not provide SOP 14-000-003 (your MDR procedures) that you stated would be updated by March 31, 2010, to be quite clear on the MDR reportability of foreign complaints.
3. Failure to submit a report to FDA within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 C.F.R. 803.50(a)(2). For example:
In your CAPA Investigation #2009-002, you stated that the initial release of the PIP trials consisted of plastic components, which were later changed to metal. However, you stated a review of the original trial [plastic] design revealed that the trials did not incorporate the same dimensional parameters as the implants, so the metal trials would also not be the same size as the implants.
For Complaint # 2008-051, #2009-008, and # 2009-010 the information provided by your firm in your "Table of related PIP Complaints" confirms that these metal trials were not properly sized and, therefore, failed to perform as intended. Having established that an oversized Trial caused or contributed to a reportable serious injury per Complaint # 2008-038, all subsequent events associated with oversized trials and in the absence of medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, would be reportable as malfunction MDRs. Complaints # 2008-051, #2009-008, and # 2009-010 met this threshold and should have been reported to FDA as malfunction MDRs.
In your response dated March 15, 2010, you committed to review complaint files from 2008 and 2009 within 30 days to ensure that there were no other problems similar to Complaint 2008-038, and that any other missed items will be reported. You did not submit the results of your review to FDA, and you did not submit the above complaints as malfunction MDR reports. Please note there is a process for submitting MDRs based on a retrospective review of your complaints. If you need to submit late MDRs, please contact Mr. William Huff, Exemptions Coordinator within the Reporting Systems Monitoring Branch (RSMB), Center for Devices and Radiological Health (CDRH). RSMB provides expertise to FDA and regulated entities on the interpretation and implementation of the MDR regulation. Mr. Huff will direct and facilitate the exemption process for you. You can reach Mr. Huff at William.Huff@fda.hhs.gov.
4. Failure to develop, implement, and maintain written MDR procedures, as required by 21 C.F.R. 803.17. For example:
a. The referenced MDR procedures, which define terms and guidelines used by your firm to determine reportability, do not provide for the timely and effective identification, communication, and evaluation of all events, including those events that occur outside the U.S., that may be subject to MDR requirements, as required by 21 C.F.R. 803.17(a)(1).
b. The MDR procedures do not establish a standardized review process or procedure for determining when an event meets the criteria for reporting, as required by 21 C.F.R. 803.17(a)(2).
c. The MDR procedures do not establish documentation and record keeping requirements for information that was evaluated to determine if an event was reportable, as required by 21 C.F.R. 803.17(b)(1).
d. The MDR procedures do not establish documentation and record keeping requirements for all medical device reports and information submitted to manufacturers and/or FDA, as required by 21 C.F.R. 803.17(b)(2).
This listing of omissions and deviations of the MDR procedures is not all inclusive. Ultimately, the responsibility rests with your firm to use your procedures effectively to comply with the requirements of 21 CFR Part 803 for determination of reportability and subsequent submission of MDRs when required.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct the violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
In addition, FDA noted nonconformances with the following Current Good manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, Customer Feedback Record 2008-038 stated the PIP 30P trial is oversized because when the doctor put the trial in, the bone fractured. An internal Ascension e-mail located in the referenced complaint file dated 5/21/08 stated that the doctor resolved the issue with a suture. Yet Part Three of Customer Feedback Record 2008-038 states "No patient harm resulted from incident" and Part Five of Customer Feedback Record 2008-038 states "No patient injury resulted from event." These conclusions are not correct because the patient received a bone fracture which required a suture.
Your response should be sent to the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Ms. Rose Ashley, Acting Compliance Officer. If you have any questions about the content of this letter please contact: Ms. Ashley at (214) 253-5218. If necessary, Ms. Ashley can arrange for a telephone conference to include representatives from the Center for Devices and Radiological Health's (CDRH's) Office of Surveillance and Biometrics (OSB) responsible for MDR information for the Office of Compliance (OC)/CDRH.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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