MAUDE Adverse Event Report: CONMED CORPORATION 6.0MM TENOLOK TENODESIS ANCHOR; SUTURE ANCHOR

Catalog Number	T60S
Medical Device Problem Codes	Human-Device Interface Problem (2949); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure cannot be verified.However, the reported lot was shipped to the customer in february of 2018 - approximately one year and four months prior to the expiration date.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.A review of the dhr found that the reported lot expired on 05-jun-2019.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the following; do not use beyond the expiration date listed on the label.The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer representative reported on behalf of the facility that the t60s, 6.0mm tenolok anchor, which was expired, was implanted into a patient on (b)(6) 2019.The expiration date was 06/2019.The customer has spoken with their ortho tech about these implants and they should be having monthly consignment checks, which i believe was done in the last two weeks.This report is being raised on the basis of device malfunction due to an expired implant being implanted into a patient.

• Brand Name: 6.0MM TENOLOK TENODESIS ANCHOR
• Common Device Name: SUTURE ANCHOR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 9147555
• Report Number: 1017294-2019-00130
• Device Sequence Number: 16851886
• Product Code: MBI
• UDI-Device Identifier: 10845854043790
• UDI-Public: (01)10845854043790(17)190605(30)1(10)886038
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2019
• Device Catalogue Number: T60S
• Device Lot Number: 886038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1