BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3101962 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02157
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 7, 2013
    Report Date
    April 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS DURING A GREAT TOE AMPUTAION ON (B)(6) 2013, IT WAS DISCOVERED THE SAGITTAL SAW ATTACHMENT HAD A PIECE BROKEN OFF. A SPARE DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM. NO FURHTER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203939 SAGITTAL SAW ATTACHMENT HWE SYNTHES GMBH 8289

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR