BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILL-SAW-ATTACHM F/532.001 532.010 532

    MDR report key: 4110139 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-01091
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED A COUPLING SIDE DEFECT. THE ATTACHMENT GETS HOT. THE ATTACHMENT IS DIRTY ON THE INSIDE AND SEVERAL ELEMENTARY PARTS ARE WORN-OUT AND DIRT GETS IN. THE ATTACHMENT WAS CLEANED AND PARTS WERE REPLACED. THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, TECHNICIAN INDICATED THE ATTACHMENT GOT HOT. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590294 OSCILL-SAW-ATTACHM F/532.001 532.010 532 HWE SYNTHES GMBH 6062

    Patients

    Seq Age Sex Outcome Treatment
    1