BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL CHUCK KEYLESS F/COMPACT AIR DRIVE+

    MDR report key: 4102764 · Received September 19, 2014

    Report

    Report Number
    8030965-2014-00806
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    February 15, 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 ADAPTOR HAS THE CONNECTION PART BROKEN DUE TO THE USE OF EXCESSIVE FORCE AND INCORRECT MOVEMENTS IN THE PROCEDURE, CREATING STRESS IN A CERTAIN POINT AND POSTERIOR BREAK. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2013. SECOND SERIAL NUMBER IS (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR AN UNKNOWN REASON. DURING THE SERVICE TECHNICIAN FOUND THAT THE CONNECTION PART OF THE MANDREL WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT#(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584326 DRILL CHUCK KEYLESS F/COMPACT AIR DRIVE+ HWE SYNTHES GMBH 10640

    Patients

    Seq Age Sex Outcome Treatment
    1