MAUDE Adverse Event Report: CONMED BIOSCREW XTRALOK; SCREW, FIXATION, BONE

Catalog Number	C8028
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.H3 other text: device not yet received.
Event or Problem Description
The distributor reported on behalf of their customer that the device, c8028, bioabsorbable interference screw,violet,10 mm x 35 mm, was used during an anterior cruciated ligament reconstruction procedure on 15dec25 when it was reported, "the screwdriver broke on the screw" there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested, and the reporter advised that the screwdriver broke inside the screw while it was being installed.Fragmentation fell into the surgical site and was retrieved using kelly clamps.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence was provided.Therefore, the reported event can not be verified.A device history record (dhr) review found a non-conformance, however, it was not related to the manufacture of the product.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 that the risk of screw breakage during initial implantation may be influenced by several factors as discussed below.These factors are of increased importance when using smaller diameter screws:a.Use only with the bioscrew universal driver (modular - c8716 or fixed handle - c8715).The bioscrew universal driver is intended for use with only linvatec bioscrew absorbable interference screws and respective 0.045 inch diameter straight guidewires.B.Full insertion of the driver within the lumen of the bioscrew xtralok absorbable interference screw is mandatory for proper implant delivery.Care must be taken to line up the lobes of the driver with the slots in the screw.Failure to ensure full engagement may result in implant breakage.Examine the driver prior to screw engagement for gouges, scratches or dents.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, c8028, bioabsorbable interference screw,violet,10 mm x 35 mm, was used during an anterior cruciated ligament reconstruction procedure on (b)(6) 2025 when it was reported, "the screwdriver broke on the screw." there was no report of injury, medical intervention, or hospitalization for the patient.Further assessment was requested, and the reporter advised that the screwdriver broke inside the screw while it was being installed.Fragmentation fell into the surgical site and was retrieved using kelly clamps.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: BIOSCREW XTRALOK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 24001900
• Report Number: 1017294-2026-00004
• Device Sequence Number: 15998468
• Product Code: HWC
• UDI-Device Identifier: 20845854014162
• UDI-Public: (01)20845854014162(17)280713(10)1476734
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K013131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: C8028
• Device Lot Number: 1476734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2025
• 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
• Patient Age: 30 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic