BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILL-SAW-ATTACHM F/532.001 532.010 532

    MDR report key: 4101354 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-00967
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    January 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 THE MECHANICS WERE IN POOR CONDITION AND THE DEVICE WARMED DURING USE. THIS WAS ATTRIBUTED TO FAULTY CARE AND MAINTENANCE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE. DURING SERVICE, THE TECHNICIAN FOUND THE DEVICE OVERHEATING. THE TECHNICIAN ALSO NOTED THE FOLLOWING, "THE DEFECT VERIFIED IN VISUAL, FUNCTIONS AND SPEED TEST CONCLUDED THAT THE ADAPTER GETS SLIGHTLY WARM WHEN TRIGGERED BY THE ENGINE AND AFTER APPLYING SOME KIND OF PRESSURE DUE TO SOME INTERNAL PARTS BEING DAMAGED POSSIBLY BY INCORRECT CLEANING PERFORMED ON THE ADAPTER SINCE WE DETECTED TRACES OF LIQUID RESIDUE INSIDE, CAUSING WEAR OF PARTS AND CAUSING THE DEFECT REPORTED." THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582021 OSCILL-SAW-ATTACHM F/532.001 532.010 532 HWE SYNTHES GMBH 9463

    Patients

    Seq Age Sex Outcome Treatment
    1