MAUDE Adverse Event Report: CONMED CORPORATION 5.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	T50S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken t50s is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.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 was found to have met all specifications prior to shipment.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: precautions: ensure proper selection of bone preparation device (drill, punch, etc.) according to anchor size selection.Inspect all instruments for damage prior to use.Ensure the anchor is properly seated on the driver tip prior to and during implantation.Avoid lateral loading while inserting the device.Maintain proper alignment during insertion of the anchor and disengagement of the delivery handle.Proper orientation and alignment of instruments is important during implantation of the tenolok tenodesis anchor to minimize possible breakage of the anchor.Breakage of the device is possible if: the bone preparation device is not inserted to the proper depth.The device is not properly aligned with the pilot hole.The device is loose or not securely attached on the delivery handle.The device inserter is used for prying.The device is advanced too deep.A small amount of forward pressure is not applied while rotating the handle.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the t50s anchor was being implanted during a rotator cuff repair with bicep tenodesis on (b)(6) 2020 when one of the wings "snapped" off as the anchor was being inserted.The component was removed using a grasper.The anchor remained implanted securely; therefore, it was not removed from the patient and an alternate device was not required.There was no harm to the patient or the user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo, fl
• MDR Report Key: 9711511
• Report Number: 1017294-2020-00035
• Device Sequence Number: 11391235
• Product Code: MBI
• UDI-Device Identifier: 20845854043780
• UDI-Public: (01)20845854043780(17)220924(30)1(10)1049324
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 09/24/2022
• Device Catalogue Number: T50S
• Device Lot Number: 1049324
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1