BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT-DRIVE

    MDR report key: 4183147 · Received October 17, 2014

    Report

    Report Number
    8030965-2014-01521
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. MANUFACTURING DATE FOR THIS DEVICE IS UNAVAILABLE. DURING PRE-REPAIR ASSESSMENT PERFORMED BY TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE COUPLING TOOL SIDE IS WORN. THIS WAS CONTRIBUTED TO NORMAL WEAR. UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4)2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MADE A BUCKLING SOUND DURING SURGERY AND STOPPED WORKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660124 RADIOLUCENT-DRIVE HWE SYNTHES GMBH 9888

    Patients

    Seq Age Sex Outcome Treatment
    1