BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2103153 · Received May 25, 2011

    Report

    Report Number
    1030489-2011-00619
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. THE TIP OF THE DRIVER HAS BROKEN OFF. THE BREAK AT THE TIP APPEARS TO BE THE RESULT OF 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 PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS FOUND THAT THE TIP OF THE DRIVER HAS BROKEN. 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 BM03M013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention