BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4013120 · Received August 15, 2014

    Report

    Report Number
    2530088-2014-10221
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED AIMING ARM WAS RECEIVED INTACT WITH VERY MINIMAL WEAR AND NO DAMAGE WHICH WOULD HAVE CONTRIBUTED TO THE SUBJECT EVENT. THE RETURNED DEVICES ARE CRITICAL COMPONENTS OF THE SYNTHES TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM WHICH ALLOWS FOR AN INTRAMEDULLARY METHOD FOR STABILIZING FEMUR FRACTURES USING IMPLANTS MADE OF TITANIUM ALLOY. THE TFN SYSTEM IS COMPOSED OF A SERIES OF CANNULATED NAILS, HELICAL BLADES, END CAPS, LOCKING BOLTS, AND SCREWS. THE TFN SYSTEM INCLUDES A 130° AIMING ARM WHICH ALONG WITH THE INSERTION HANDLE ARE USED TO PROPERLY POSITION AND SECURE TFN¿S. DRAWINGS 357_366 (REV D) (11JAN11) AND 357_411 (REV C) (07NOV02) WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY OF THE SUBJECT PARTS. IN ORDER TO RECREATE THE COMPLAINT CONDITION, THE RETURNED 130° AIMING ARM AND INSERTION HANDLE WERE MATED USING THE FOLLOWING KNOWN GOOD PARTS: BLADE GUIDE SLEEVE (357.369) (4545108), BUTTRESS NUT (357.371) (5013309), 130° TFN (456.477) (4328328), HELICAL BLADE INSERTER (357.372) (5173134), HELICAL BLADE COUPLING SCREW (357.377) (4818089), 115MM HELICAL BLADE (456.308) (6432748), CONNECTING SCREW (357.397) (4546891), AND TIGHTENED USING A BALL HEXAGONAL SCREWDRIVER 8MM (357.515) (4936924). AFTER ATTEMPTING TO RECREATE THE COMPLAINT CONDITION OVER TEN TIMES USING THE SAMPLE TFN AND A SAWBONES FEMUR SAMPLE, THE HELICAL BLADE REPEATEDLY ENDED UP ALIGNED PROPERLY AS INTENDED. ALTHOUGH DISTAL LOCKING COULD NOT BE FULLY RECREATED DUE TO A LACK OF NECESSARY KNOWN GOOD PARTS, THE OVERALL ALIGNMENT ACHIEVED USING THE AVAILABLE PARTS, INCLUDING PROXIMAL LOCKING WITH THE HELICAL BLADE, INDICATES THAT THE RETURNED PARTS DID NOT CONTRIBUTE TO A MISALIGNMENT DURING DISTAL LOCKING. FOLLOWING INSPECTION OF THE RETURNED PARTS AND THE ATTEMPTED RECREATION OF THE COMPLAINT CONDITION, IT COULD NOT BE REPLICATED, AND NO DEFINITIVE ROOT CAUSE FOR THE COMPLAINT COULD BE DETERMINED. THE RETURNED INSERTION HANDLE AND AIMING ARM FUNCTIONED WELL AND THE COMPLAINT CONDITION WAS THEREFORE UNCONFIRMED. USING THE RETURNED PARTS AND THE DETAILS SURROUNDING THE COMPLAINT, IT WAS NOT POSSIBLE TO RECREATE OR ACCURATELY IDENTIFY THE ROOT CAUSE. CONSIDERING THE DAMAGE TO THE INSERTION HANDLE AND THE POSSIBILITY OF THE INSERTION CONSTRUCT BECOMING LOOSE DURING HAMMERING, IT IS POSSIBLE THAT THE CONNECTING SCREW WAS NOT TIGHTENED FOLLOWING HAMMERING, AS IS RECOMMENDED IN THE TFN TECHNIQUE GUIDE (J3900-I). 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO RELEVANT ISSUES DURING MANUFACTURING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 A DISTAL LOCKING SCREW BECAME MISALIGNED DURING THE PLACEMENT OF A SHORT INTERTROCHANTERIC NAIL FOR A HIP FRACTURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM OR SURGICAL TIME DELAY REPORTED. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489524 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4634014

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR