BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 2962137 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-10151
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PRODUCT EVALUATION REVEALED THAT THE SCREWS HOLDING THE CUTTERS WERE NO LONGER ATTACHED. WELDS ARE BROKEN. THREADS ARE STRIPPED. THE INSTRUMENT APPEARS TO HAVE UNDERGONE SIGNIFICANT MISUSE TO CAUSE THE DAMAGE DESCRIBED ABOVE. THE FUNCTIONAL DESIGN REQUIREMENTS, RISK ANALYSIS, AND DRAWINGS WERE REVIEWED TO BE ACCEPTABLE. IT IS CONCLUDED THAT DUE TO THE DAMAGE TO THE INSTRUMENT, THE DEVICE APPEARS TO BE SIGNIFICANTLY MISUSED. IT IS UNCLEAR HOW THIS DAMAGE HAS OCCURRED.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROD CUTTER (03.614.021) FELL APART WHEN TRYING TO CUT THE ROD. NOTHING BROKE OFF INTO PATIENT, NOTHING TO RETRIEVE. NO HARM TO PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66105 ROD CUTTER HXZ SYNTHES GMBH T941323

    Patients

    Seq Age Sex Outcome Treatment
    1