BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX

    MDR report key: 4316530 · Received December 10, 2014

    Report

    Report Number
    1719045-2014-10675
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 12, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL MANUFACTURING DATE: NOVEMBER 4, 2014. REVIEW OF THE DEVICE HISTORY RECORD REPORTED ORCHID UNIQUE MANUFACTURED THE CANNULATED CONNECTING SCREW, P/N 03.010.404, AND LOT #U210481 ON PO # (B)(4). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED OCTOBER 18, 2014, AND SYNTHES FINAL INSPECTION SHEET # (B)(4), REVISION ¿D¿ (33/33 FOR PO #(B)(4) AND 51/60 FOR PO #(B)(4)). THE PARTS WERE RELEASED TO THE WAREHOUSE ON OCTOBER 22, 2014 (PO #(B)(4)) AND NOVEMBER 4, 2014 (PO #(B)(4)). THERE WAS ONE NONCONFORMANCE REPORT (NCR) (B)(4) ISSUED AGAINST (B)(4) PARTS ON PO# (B)(4) ON OCTOBER 28, 2014 FOR FAILED THREAD GAGE; (B)(4) PARTS WERE RETURNED TO THE SUPPLIER AND THE NCR WAS CLOSED OCTOBER 31, 2014.THE CANNULATED CONNECTING SCREW WAS MADE TO THE SYNTHES DRAWING P/N 03.010.404, REVISION ¿A¿, RELEASED ON SEPTEMBER 22, 2008. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE 03.010.404 CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSTRUMENTS FOR NAILS-EX WAS RECEIVED INTACT. IT SHOWS MILD WEAR AND DISCOLORATION AT BOTH THE DISTAL AND PROXIMAL ENDS. THE DEVICE WAS RETURNED AND REPORTED TO HAVE CONTRIBUTED TO A MISALIGNMENT PREVENTING A DRILL BIT FROM PASSING THROUGH THE PROXIMAL SCREW HOLE IN THE TIBIAL NAIL. THIS CONDITION IS UNCONFIRMED; WHEN ALL THE RETURNED PARTS WERE ASSEMBLED ALONG WITH A 04.004.343, LOT#7410724 TITANIUM CANNULATED TIBIAL NAIL-EX TEST SAMPLE, THE INSTRUMENTS PROPERLY TARGETED ALL PROXIMAL LOCKING HOLES. IT IS LIKELY THAT SOFT TISSUE OBSTRUCTED THE PATH OF THE DRILL BIT AND CAUSED THE DRILL BIT TO MISS THE LOCKING HOLE. THE DEVICE DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. ADDITIONAL RELEASE TO WAREHOUSE DATE: NOVEMBER 4, 2014. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPRAPATELLAR TIBIAL NAILING PROCEDURE, A DRILL BIT HIT THE NAIL AND WOULD NOT PASS THROUGH AS THE SURGEON WAS DRILLING THOUGH THE GUIDE. ALL CONNECTIONS WERE CHECKED, AND ALL WERE TIGHT AND THE ARM WAS NOT WOBBLING. WHEN REPEATED, THE DRILL BIT HIT THE NAIL AGAIN. THE SURGEON THEN PULLED THE AIMING ARM OFF AND USED PERFECT CIRCLES TECHNIQUE AND THE SAME PROCEDURE PROXIMALLY. THE PROCEDURE WAS SUCCESSFUL. THERE WAS A TEN MINUTE SURGICAL DELAY. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801582 CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX GUIDE FZX SYNTHES MONUMENT U210481

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR