BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT

    MDR report key: 3132665 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02392
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A FEMORAL OSTEOTOMY PROCEDURE ON (B)(6) 2013, THE OSCILLATING SAW ATTACHMENT DID NOT VIBRATE. IT IS REPORTED A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. NO DELAY IN PROCEDURE WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235461 SAGITTAL SAW ATTACHMENT HWE SYNTHES GMBH 8405

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR