BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130° RADIOLUCENT TARGETING ARM

    MDR report key: 19961205 · Received August 12, 2024

    Report

    Report Number
    1220246-2024-07136
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    UDI-DI
    00848665028645
    PMA / PMN Number
    K021008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED 1268-100 TARGETING ARM LOT NUMBER: 210295 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED NO PROBLEMS WITH THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ASSEMBLING THE 1268-100 TARGETING ARM WITH A 1059-390 TROCHANTERIC NAIL LOT NUMBER: 211400 AND A LAG SCREW ASSEMBLY CONSISTING OF A 1099-100 TELESCOPING LAG SCREW LOT NUMBER: 220943. A 5031-000 LOCKING TOOL LOT NUMBER: 212675-090, A 5032-000 COMPRESSION SLEEVE LOT NUMBER: 212018, A 5030-000 LAG SCREW INSERTER LOT NUMBER: 212668 AND A 5033-100 CAPTURING ROD LOT NUMBER: 220097. IT WAS NOTED THAT WHEN THE LAG SCREW ASSEMBLY WAS PLACED THROUGH THE 1268-100 TARGETING ARM, THE LAG SCREW WAS ABLE TO ALIGN WITH THE 1059-390 TROCHANTERIC NAIL AS INTENDED. FURTHER FUNCTIONAL TESTING OF THE BUTTONS OF THE DEVICE REVEALED NO PROBLEM WITH THE DEVICE. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 07/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT A 1268-100 TARGETING ARM WAS MISALIGNED AND REPEATEDLY MISSED THE LAG SCREW. AND A 0312-200 PIN GUIDE WAS GETTING STUCK IN THE SLEEVE SPRING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935363 130° RADIOLUCENT TARGETING ARM ORTHOPEDIC MANUAL SURG INSTR HSB ARTHREX, INC. 130° RADIOLUCENT TARGETING ARM 210295 00848665028645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown