BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1083803 · Received July 25, 2008

    Report

    Report Number
    1030489-2008-00400
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 5, 2007
    Report Date
    April 5, 2007
    Manufacturer
    MEDTRONIK SOFAMORE DANEK
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR WHERE EVALUATION CONFIRMED THE FRACTURE OF THE INSTRUMENT TIP. NO EVIDENCE WAS NOTED OF MFG NON-CONFORMANCE DURING PRODUCT ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE INSTRUMENT BREAKAGE DID NOT RESULT IN PT COMPLICATIONS PT. NEVERTHELESS, WE ARE FILING AN MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OSTEOTOME BROKE DURING USE. ALTHOUGH, THE INSTRUMENT WAS USED IN SURGERY, NO PT COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 25 MM OSTEOTOME HWM MEDTRONIK SOFAMORE DANEK NA CB05D016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK