BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS

    MDR report key: 3242216 · Received July 23, 2013

    Report

    Report Number
    8030965-2013-04451
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SYNTHES GMBH
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE MANUFACTURING EVALUATION ARE AS FOLLOWS: THE EXAMINATIONS AND FUNCTIONAL TESTS PERFORMED SHOWED NO DISCREPANCIES. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SAW BLADES DISSOLVED. THEY WERE TIGHTENED INDEPENDENTLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342976 SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS HWE SYNTHES GMBH SER.NO. 3914

    Patients

    Seq Age Sex Outcome Treatment
    1