MAUDE Adverse Event Report: CONMED LARGO 6.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	T60S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, the provided photographic evidence exhibits the reported event.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.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, for this device family and failure mode.During this same time frame 8,102 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.Per the instructions for use, the user is advised the following: surgeon must choose proper implant size based on specific procedure and patient history.The ifu precautions the user to 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.Ensure the free ends of the suture are securely locked in place around cleat on delivery handle.Avoid lateral loading while inserting the device.Maintain proper alignment during insertion of the anchor and disengagement of the delivery handle.Additionally, detailed instructions on the use and limitations of the device should be given to the patient.The patient should be told to follow the surgeon¿s protocol for postoperative management.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the t60s 6.0mm tenolok tenodesis anchor with one no.2 hi-fi suture was implanted on (b)(6) 2023 and on (b)(6) 2023 a revision biceps repair procedure was completed as the dr.¿had a tenolok fail after the original surgery on (b)(6).¿.The original surgery was a biceps repair that was completed with no complications.The patient is recovering and no extended stay at the hospital was required.This report is being raised due to the reported injury of revision surgery needed for a failed implant.

• Brand Name: 6.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 17018479
• Report Number: 1017294-2023-00050
• Device Sequence Number: 14993391
• Product Code: MBI
• UDI-Device Identifier: 10845854043790
• UDI-Public: (01)10845854043790(17)251214(30)1(10)1289038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2025
• Device Model Number: T60S
• Device Catalogue Number: T60S
• Device Lot Number: 1289038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic