BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3963798 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03331
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: MACROSCOPIC EXAMINATION CONFIRMS PROBE BENT IN MULTIPLE LOCATIONS, WITH PROBE TIP BREAKAGE APPROX. ~23MM FROM THE PROBE TIP END. OPTICAL EXAMINATION REVEALS A FAIRLY TORTUOUS FRACTURE SURFACE, CONSISTENT WITH BEND STRESS OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 1 INCH OF THE TIP OF THE SHAFT BROKE OFF. THE TIP WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441052 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PROBE HXB MSD BARTLETT MFG NA ID09D002

    Patients

    Seq Age Sex Outcome Treatment
    1