BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1903881 · Received November 20, 2010

    Report

    Report Number
    1030489-2010-01483
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 30, 2010
    Report Date
    November 2, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP OF THE DRIVER WAS FOUND SHEARED OFF. THE BROKEN PIECE WAS NOT RETURNED. THE BREAKAGE OCCURRED AT THE LEVEL OF THE RUN-OUT. THE BREAKAGE APPEARANCE IS TYPICAL OF TORSIONAL OVERLOADING. NO DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE.

    Additional Manufacturer Narrative · 1

    THE DRIVER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE WHILE REMOVING A SET SCREW DURING A SURGICAL PROCEDURE. 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 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. SA09J172

    Patients

    Seq Age Sex Outcome Treatment
    1