BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 3072256 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-11034
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE VERY TIP OF THE RIGHT HAND JAW WAS BROKEN OFF. THERE WAS ALSO A DENT IN BOTH JAWS APPROX HALF WAY DOWN. THE CUTTER DOES NOT CORRESPOND TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE AS THE DRAWING SPECIFIES A MATERIAL WHICH IS NOT SUITABLE FOR THIS APPLICATION ACCORDING TO MATERIALS MANAGER. A CAPA EVALUATION FOR A PREVIOUS COMPLAINT WAS PERFORMED. (B)(4). WE CAN ALSO NOT RULE OUT MISUSE OR BAD TREATMENT. TOO MUCH FORCE WAS APPLIED TO THE TIPS CAUSING ONE TO BREAK. THIS COMPLAINT WAS DEEMED INVALID.

    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.

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED THAT THE TIP OF THE ROD CUTTER WAS BROKEN. NO INFORMATION WAS OBTAINABLE CONCERNING THE DETAILS OF THE EVENT OR THE CAUSE OF BREAKAGE. NO HARM TO ANY PATIENT WAS REPORTED. THE DEVICE IS AVAILABLE TO RETURN. EVENT #1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175632 ROD CUTTER HXZ SYNTHES GMBH T921892

    Patients

    Seq Age Sex Outcome Treatment
    1