BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIX-SLEEVE

    MDR report key: 3185662 · Received June 24, 2013

    Report

    Report Number
    1719045-2013-01687
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2011037
    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. (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND PERFORMANCE TESTING SHOWED THAT THE RESPECTIVE CLAMPING CASING MOVES OVER THE DRILL AND THEREFORE DOES NOT LOCK CORRESPONDINGLY. THERE IS WEAR ON THE HEAD OF THE DRILL SLIDE. THIS DEALS WITH AN ARTICLE THAT WAS ALREADY RECALLED IN APRIL 2011 VIA RECALL 2011037, AND AN INTERNAL CORRECTIVE ACTION WAS OPENED TO ADDRESS THIS ISSUE. THE DRILL DESIGN WAS REVISED IN ORDER TO PREVENT SUCH PROBLEMS IN THE FUTURE (ALREADY AVAILABLE ON THE MARKET). THE RETURNED ARTICLES CORRESPOND WITH THE RESPECTIVE PREVIOUS VERSIONS. THIS COMPLAINT IS VALID.

    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.REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPING CASING MOVES BACKWARD DURING DRILLING WITH THE STAGE DRILLER ON BOTH TROCHANTERIC FIXATION NAIL (TFN) SETS. THERE IS THE RISK OF DRILLING THROUGH THE FEMUR HEAD. THE PATIENT, HOWEVER, DID NOT HAVE ANY DAMAGE, AS THE DEFECTIVE PARTS WERE IMMEDIATELY BROUGHT OUT OF CIRCULATION. THIS IS REPORT 2 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284837 FIX-SLEEVE FZX SYNTHES MONUMENT 6623811

    Patients

    Seq Age Sex Outcome Treatment
    1