BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL

    MDR report key: 4110169 · Received September 23, 2014

    Report

    Report Number
    8030965-2014-00521
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 TECHNICIAN, IT WAS NOTED THAT THE CHUCK JAW WAS BROKEN. THE DRILL CHUCK AND SEALS WERE REPLACED AND GENERAL SERVICE WAS EXECUTED. DEVICE REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT (B)(6) CHUCK FOR TRS DID NOT WORK. THIS IS REPORT 1 OF 1 FOR EVENT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590812 DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL HWE SYNTHES GMBH 3010

    Patients

    Seq Age Sex Outcome Treatment
    1