BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTACHM F/COMPACT AIR DRIVE+POWER DRIVE

    MDR report key: 3161314 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-02690
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    March 28, 2011
    Report Date
    April 15, 2011
    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

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE TOOLS FELL APART DUE TO HIGH MECHANICAL LOADING DURING LONG TERM IN USE. DEVICE HISTORY RECORDS IDENTIFY THAT THIS DEVICE WAS NEVER RECEIVED FOR SERVICE AND MAINTENANCE FOR MORE THAN 10 YEARS. THEREFORE, WE CONCLUDE MISSING MAINTENANCE AS ROOT CAUSE FOR THIS PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOP PART OF THE REDUCTION DRIVE UNIT CAME OFF DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263293 ATTACHM F/COMPACT AIR DRIVE+POWER DRIVE HWE SYNTHES GMBH 3629

    Patients

    Seq Age Sex Outcome Treatment
    1