BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION TOOL F/SPONDYLOLISTH

    MDR report key: 3192938 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03602
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    February 10, 2012
    Report Date
    February 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE TWO THREADS OF THE SPONDYLOLISTHESIS TOOL ARE NOT FUNCTIONING. THE DISTRACTION INSTRUMENT CAN ONLY BE OPENED AND CLOSED WITH DIFFICULTY. THIS CAN HAPPEN WHEN THE INSTRUMENT IS CONTINUOUSLY USED WITHOUT THE THREAD BEING DRAWN COMPLETELY. REGARDING THE DISTRACTION INSTRUMENTS, THE LOCKING MECHANISM IS JAMMED AND DOES NOT RUN WELL. THE INNER PIN IS CORRODED AND DOES NOT MOVE ACCORDINGLY. FURTHERMORE, AFTER A REVIEW OF THE DATA OF THE MANUFACTURER IT SHOWED THAT THIS INSTRUMENT MEETS TOTALLY OUR REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS ARE DAMAGED AND THE CLAMP IS JAMMED. IN THE SPONDY TOOL BOTH THREADS ARE NOT FUNCTIONING. BOTH INSTRUMENTS WERE USED DURING OPERATION. THE DISTRACTION INSTRUMENT DOES NOT OPEN AND CLOSE EASILY NOW. THOSE WERE ALSO USED DURING THE OPERATION. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294353 REDUCTION TOOL F/SPONDYLOLISTH HSZ SYNTHES GMBH 7539567

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR