BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR

    MDR report key: 4111096 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-00919
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    March 12, 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 ADAPTER HAS A BROKEN TOOTH. THIS IS ATTRIBUTED TO FAULTY HANDLING. A REPLACEMENT WAS SENT TO THE CUSTOMER ON (B)(4) 2013. SECOND SERIAL NUMBER IS (B)(4). (B)(6). PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE FOR AN UNKNOWN REASON. DURING SERVICE, TECHNICIAN FOUND THAT THE ATTACHMENT HAD A BROKEN TOOTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591633 CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR HWE SYNTHES GMBH 10640

    Patients

    Seq Age Sex Outcome Treatment
    1