BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION SCREW SET

    MDR report key: 22962822 · Received September 4, 2025

    Report

    Report Number
    1220246-2025-03730
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 15, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO A MANUFACTURING ISSUE. DUE TO THE UNPACKAGED STATE OF THE DEVICE, THE AS RECEIVED CONDITION CANNOT BE VERIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8725-50H COMPRESSION FT SCREW (FROM A LOANER SET) BROKE OFF INSIDE THE BONE DURING INSERTION. THE SCREW FRACTURED APPROXIMATELY ONE-THIRD OF THE WAY FROM THE HEAD, WITH ABOUT 35 MM EMBEDDED IN THE BONE. THE REMAINING PORTION OF THE SCREW WAS RETRIEVED, WHILE THE EMBEDDED FRAGMENT WAS LEFT IN THE BONE. A K-WIRE WAS SUBSEQUENTLY PLACED AT THE SITE. ADDITIONALLY, DURING THE PROCEDURE, THE AR-8738S COMPRESSION SCREW SET (ALSO FROM A LOANER SET) WAS FOUND TO BE MISSING AN AR-8737-61 SCREW REMOVER, EASY-OUT, 2.5 MICRO COMPRESSION FT, AND AN AR-8737-59 SCREW REMOVER, TREPHINE/EXTRACTOR, 2.5 MICRO/3.5 MINI CFT. DUE TO THE ABSENCE OF THESE TWO INSTRUMENTS, THE SCREW COULD NOT BE REMOVED. THE CASE WAS COMPLETED USING NON-ARTHREX K-WIRES TO STABILIZE THE FRACTURE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES, AND WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED IS UNCERTAIN. THIS OCCURRED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435195 COMPRESSION SCREW SET ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. COMPRESSION SCREW SET

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown