BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2210037 · Received August 12, 2011

    Report

    Report Number
    1030489-2011-01044
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. VISUAL CONFIRMED THE TIP IS BROKEN. DAMAGE NOTED TO FRACTURE SURFACES. THE SHAFT OUTER SURFACE IS FAIRLY FLAT WITH CIRCULAR MATERIAL FLOW INDICATIVE OF OVERLOAD. THE INNER PORTION OF THE SHAFT DISPLAYS A FAIRLY FLAT FRACTURE SURFACE WITH PROGRESSIVE STRIATIONS THAT ARE INDICATIVE OF FATIGUE. 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 TIP OF THE FIXED SCREWDRIVER BROKE OFF DURING A SPINAL SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA PT8852

    Patients

    Seq Age Sex Outcome Treatment
    1