BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1820049 · Received August 20, 2010

    Report

    Report Number
    1030489-2010-01076
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Report Date
    July 30, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATELY, 3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALED FAIRLY BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. PLASTIC DEFORMATION JUST BELOW FRACTURE SURFACE NOTED, AND IS ALSO CONSISTENT WITH OVERLOAD. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWDRIVER'S TIP BROKE DURING TIGHTENING THE SET SCREW FOR A POSTERIOR FIXATION PROCEDURE AT L4-S1. THE BROKEN OFF TIP REMAINED IN THE HOLLOW PART OF THE SET SCREW AND WAS REMOVED. NO PT COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX WARSAW ORTHOPEDIC INC. NA PT04B028

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT:| SET SCREW