BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1083812 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00393
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 4, 2006
    Report Date
    May 9, 2006
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR WHERE EVALUATION CONFIRMED THE FRACTURE OF THE INSTRUMENT TIP. NO EVIDENCE WAS NOTED OF MFG NON-CONFORMANCE OR DESIGN RELATED ISSUES DURING PRODUCT ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE INSTRUMENT BREAKAGE DID NOT RESULT IN PT COMPLICATIONS. NEVERTHELESS, WE ARE FILLING AN MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TORX 20 SHAFT WAS BROKE DURING TIGHTENING. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT DRIVER LXH WARSAW ORTHOPEDIC INC. NA BM03M004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK