BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 3671137 · Received March 10, 2014

    Report

    Report Number
    1719045-2014-10044
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ONE PART # 357.369 WAS RECEIVED. THE INSTRUMENT IS IN GOOD CONDITION WITH A FEW SCRATCHES ON THE BODY CONSISTENT WITH MODERATE TO HEAVY USE. ONE THREAD IS SLIGHTLY DINGED AND DAMAGED. LASER MARKING IS LEGIBLE. SEVERAL INSTRUMENTS WERE RECEIVED WITH A COMPLAINT CATEGORY OF MISALIGNED. THE DRAWING FOR EACH INSTRUMENT WAS REVIEWED AND IS DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE DEVICES ARE IN GOOD CONDITION, WITH ONLY MINOR SCRATCHES AND DINGS CONSISTENT WITH REGULAR USE. THE RETURNED INSTRUMENTS ARE PART OF THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN) AND THEIR PROPER USE AND MAINTENANCE IS ADDRESSED IN TECHNIQUE GUIDES J10382-B, J9516-C, AND J3900-I. THE RETURNED DEVICES WERE ASSEMBLED TOGETHER AND THERE WERE NO MISALIGNMENT OR ASSEMBLY ISSUES. A KNOWN GOOD LAG SCREW (04.032.100 / LOT#6538897) AND NAIL (456.315 / LOT#6700338) WERE ATTACHED AND ALIGNED PROPERLY AS INTENDED DURING THIS EVALUATION. THIS PROCEDURE IS TECHNIQUE DEPENDENT, AND THE CANNULATED CONNECTING SCREW MUST BE TIGHTENED FOLLOWING INSERTION OF THE NAIL (TECHNIQUE GUIDE J10382-B). THIS COMPLAINT CONDITION MAY HAVE RESULTED FROM THE CANNULATED CONNECTING SCREW BEING LOOSE AND/OR IT COULD HAVE BEEN CAUSED BY DEFLECTIONS FORCES FROM THE SOFT TISSUE. THE CAUSE OF THIS COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. ALL RETURNED PARTS ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. SINCE THE COMPLAINT CONDITION COULD NOT BE REPLICATED WITH KNOWN GOOD COMPONENTS AVAILABLE AT THE CHU, THIS COMPLAINT IS UNCONFIRMED. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. AVALIGN TECHNOLOGIES ¿ NEMCOMED MANUFACTURED THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS, P/N 357.369, AND LOT NUMBER 6984106 FOR PO (B)(4). THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED (B)(4) 2012) INDICATES THE PARTS WERE MANUFACTURED TO P/N 357.369, REVISION ¿F¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET COMPLETED (B)(4) 2012. THERE WERE NO NCR¿S GENERATED DURING THE PRODUCTION OF THIS LOT. P/N 357.369 IS MADE FROM DRAWING, 357.369, REVISION ¿F¿, RELEASED ON JUNE 29, 2006. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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

    DURING INSERTION OF A TROCHANTERIC FIXATION NAIL CONSTRUCT, ISSUES OCCURRED WITH THE TARGETING OF THE HELICAL BLADE AND INTERLOCKING SCREW. DUE TO THE REPORTED DIFFICULTIES, THE HELICAL BLADE WAS NICKED WHERE IT HAD CONTACTED THE NAIL. CONSEQUENTLY, A LAG SCREW WAS USED IN PLACE OF THE HELICAL BLADE. IN ADDITION, THE DISTAL LOCKING SCREW TARGETED POSTERIOR TO THE NAIL SO THE SURGEON INSERTED THE DISTAL LOCKING SCREW MANUALLY. THIS RESULTED IN A REPORTED 20 - 30 MINUTES ADDED TO THE PROCEDURE. THIS COMPLAINT INVOLVES 12 DEVICES. THIS IS REPORT 6 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142950 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES MONUMENT 6984106

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR