BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11/8 F/LOCK-SCR Ø6 TURQUO

    MDR report key: 3161406 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03056
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 15, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING RECORDS OF THE COMPLAINED DEVICE WERE REVIEWED AND SHOWS FULL CONFORMITY TO THE SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REOPERATION FOR THE DISTAL FEMORAL FAULTY UNION INSERTION OF DFN12MM-240MM NAIL WAS APPLIED TO THIS REOPERATION. THE SURGEON USED THE HAMMER FOR INSERTION WITH THE PAD WHICH HAS BEEN CHECKED DRY IN ADVANCE, AND INSERTED 6.0MM LOCKING SCREW AND THE SPIRAL BLADE. AFTER THAT, THE SURGEON DRILLED THE DISTAL HOLE WHICH IS ONE OF TWO PROXIMAL HOLES OVER THE AIMING DEVICE. AND THEN INSERTED THE LOCKING BOLT. THE SURGEON DRILLED THE PROXIMAL ONE AMONG THE TWO HOLES, BUT FOUND THE INTERFERENCE WITH THE NAIL. THE TIP OF THE DRILL SLEEVE WOULD NOT REACH TO THE BONE AND THERE WERE APPROXIMATELY A FEW CM GAPS BETWEEN THE TIP OF THE SLEEVE AND THE BONE. THE ROOT OF THE PROTECTION SLEEVE REACHED TO THE AIMING DEVICE, THOUGH. THE SURGEON REMOVED THE DRILL SLEEVE AND DRILLED ADJUSTING IN ALL DIRECTIONS OVER THE PROTECTION SLEEVE, AND INSERTED THE LOCKING BOLT. AFTER INSERTION, THE DOCTOR REMOVED THE CONNECTING SCREW AND THE DEVICES WITH PIN WRENCH. IN EACH CONNECTION, THERE WAS NO SERIOUS LOOSENESS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263111 PROTECT SLEEVE 11/8 F/LOCK-SCR Ø6 TURQUO FZX SYNTHES GMBH 1086436

    Patients

    Seq Age Sex Outcome Treatment
    1