MAUDE Adverse Event Report: CONMED CONMED; orthopedic manual surgical instrument

Catalog Number	97.10015
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot 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 (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 21 reports, regarding 21 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised that if the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.Avoid lateral stresses to the instruments, or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.Do not use if parts are broken, cracked, or worn, or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: orthopedic manual surgical instrument
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED Largo; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 525 french rd; utica, NY 13502 ; +1(727)470-8358
• MDR Report Key: 50175585
• Report Number: 1017294-2026-00145
• Device Sequence Number: 10035066
• Product Code: LXH
• UDI-Device Identifier: 10845854018972
• UDI-Public: (01)10845854018972(11)251014(10)1499893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Catalogue Number: 97.10015
• Device Lot Number: 1499893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown