MAUDE Adverse Event Report: CONMED LARGO THREVO, LINVATEC SRS, HI-FI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CF6160HN
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.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.A two-year lot history review shows a total of one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, for this device family and failure mode.During this same time frame 5,034 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 0.0002.Per the instructions for use, the user is advised to 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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported that the that the cf6160hn 5.0mm suture anchor w/3 hi-fi #2(5 metric) sutures w/needles device was being used during an mcl repair procedure on (b)(6) 2025 when it was reported ¿implants was used during or and had expiry date of 04/09.¿.Further assessment questioning found the expiration date was not checked before implantation of the device.Operation successfully performed.¿pharmacie noticed that the implant that was used was expired.¿.It was also confirmed that device did not malfunction in any way during the procedure.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: THREVO, LINVATEC SRS, HI-FI
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 23633970
• Report Number: 1017294-2025-00120
• Device Sequence Number: 21452014
• Product Code: MBI
• UDI-Device Identifier: 20845854018467
• UDI-Public: (01)20845854018467(17)250904(30)1(10)1114544
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: 09/04/2025
• Device Catalogue Number: CF6160HN
• Device Lot Number: 1114544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic