BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2100989 · Received May 24, 2011

    Report

    Report Number
    1030489-2011-00616
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 6, 2010
    Report Date
    April 1, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DRIVER WAS RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMED TWO ADJACENT SCREWDRIVER BLADES BROKE OFF; THE BROKEN PIECES WERE NOT RETURNED. THE HANDLE WAS CRACKED. MICROSCOPIC EXAMINATION REVEALED A QUASI-BRITTLE FRACTURE SURFACE WITH NO INDICATION OF FATIGUE; CONSISTENT WITH EXCESSIVE TORSIONAL FORCE. WITNESS MARKS WERE NOTED ON THE LOCKSCREW INTERFACE AREA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED; THE HANDLE AND TIP WAS BROKEN TOO. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT SCREWDRIVER HXX WARSAW ORTHOPEDIC, INC. 50046

    Patients

    Seq Age Sex Outcome Treatment
    1