BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1990387 · Received February 15, 2011

    Report

    Report Number
    1030489-2011-00128
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    THE SUPERIOR SHAFT IS BROKEN AT THE CENTERLINE OF THE DYNAMIC JAW PIVOT PIN. OPTICAL EXAMINATION OF FRACTURE SURFACE DISCOVERED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER TO INDUCE FRACTURE OF THE SHAFTS ARE CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS FOUND THAT THE SIDE PIT OF THE INSTRUMENT TIP CRACKED AFTER IT WAS USED IN THE 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 MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA GZ06L106

    Patients

    Seq Age Sex Outcome Treatment
    1