BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW-ATTACHMENT F/TRS

    MDR report key: 3191530 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03749
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE LOCKING KNOB ON THE SAGITTAL SAW ATTACHMENT IS STUCK AND DOES NOT OPEN COMPLETELY TO EXCHANGE THE SAW BLADE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291549 SAGITTAL SAW-ATTACHMENT F/TRS HWE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1