BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF-QC F/TRS

    MDR report key: 4171626 · Received October 14, 2014

    Report

    Report Number
    8030965-2014-01585
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 THE COMPLAINT WAS NOT CONFIRMED WITH THIS DEVICE. NORMAL MAINTENANCE WAS PERFORMED AND THE DEVICE WAS SENT BACK TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRS GOT SO HOT DURING USAGE THAT THE SAW ATTACHMENT COULD NOT BE CHANGED ANYMORE. IT ALSO STATED THAT THE CUSTOMER DID NOT KNOW WHICH DEVICE CAUSED THE PROBLEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650123 AO/ASIF-QC F/TRS HWE SYNTHES GMBH 1075

    Patients

    Seq Age Sex Outcome Treatment
    1