BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2250522 · Received September 16, 2011

    Report

    Report Number
    1030489-2011-01172
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 17, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD ON THE DRIVER IS WORN OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX WARSAW ORTHOPEDIC, INC. NA BM04J010

    Patients

    Seq Age Sex Outcome Treatment
    1