BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 4180020 · Received October 17, 2014

    Report

    Report Number
    2530088-2014-10313
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 20, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT: THE COMPLAINT CONDITION IS UNCONFIRMED AS THE MISALIGNMENT COULD NOT BE REPLICATED. THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE AND IT IS MOST LIKELY THAT THE METHOD OF USE OF NOT HAVING A TIGHT CONNECTION BETWEEN ALL OF THE COMPONENTS RESULTED IN THE COMPLAINT CONDITION. HOWEVER, WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO CONFIRM THIS WAS THE CAUSE OF THE NOTED FAILURE. THE AIMING ARM SHOWS SURFACE SCRATCHES AND NICKS OVER THE LENGTH OF THE DEVICE SUCH THAT THE ANODIZED LAYER HAS BEEN SCRAPED OFF IN AREAS. THE MAJORITY OF THE WEAR IS CONCENTRATED ON THE EDGES OF THE DEVICE. THE RETURNED BLADE GUIDE SLEEVE, LOT NUMBER 5103087, WAS MANUFACTURED DECEMBER, 2006. IT WAS RECEIVED WITH NICKS ON THE THREADS AND THE PROXIMAL END SHOWS DENTS NEXT TO THE GROOVES. THESE DENTS ALIGN WITH THE HELICAL BLADE INSERTER GUIDE PINS AND THEREFORE SHOW EVIDENCE OF FORCEFUL MISALIGNMENT OF THE HELICAL BLADE INSERTER INTO THE GUIDE SLEEVE. THE REMAINDER OF THE DEVICE SHOWS WEAR AND SURFACE SCRATCHES. THE RETURNED INSERTION HANDLE, LOT NUMBER 5369212, WAS MANUFACTURED MAY, 2007. IT WAS RECEIVED WITH SURFACE SCRATCHES OVER THE LENGTH OF THE DEVICE. THERE IS A SIGNIFICANT DENT ON THE PROXIMAL SIDE OF THE DEVICE WHERE THE HAMMER GUIDE WOULD ATTACH. THE BALANCE IS IN GOOD CONDITION. TO REPLICATE THE COMPLAINT CONDITION, TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL (PART # 456.477, LOT # 4328328), CANNULATED CONNECTING SCREW (PART # 357.397, LOT # 4546891), A BUTTRESS/COMPRESSION NUT (PART # 357.371, LOT # 5013309), A HELICAL BLADE COUPLING SCREW (PART # 357.377, LOT # 4818089), A HELICAL BLADE INSERTER (PART # 357.372, LOT # 5173134) AND HELICAL BLADE (PART # 456.308, LOT # 6432748) WERE USED WITH THE RETURNED DEVICES. THE CONSTRUCT WAS ASSEMBLED TO THESE KNOWN GOOD PARTS AND AT NO TIME DID THE CONSTRUCT FAIL TO PROPERLY ALIGN. THUS, THE COMPLAINT CONDITION IS UNCONFIRMED. IT IS IMPORTANT TO HAVE ALL COMPONENTS TIGHTLY CONNECTED IN ORDER TO ENSURE PROPER ALIGNMENT. IT IS ALSO LIKELY THAT HAMMERING AND FORCEFUL MISALIGNMENT OF THE HELICAL BLADE INSERTER LOOSENED THE CONNECTING SCREW WHICH ALLOWED THE DEVICES TO BE FORCED OUT OF ALIGNMENT AND GENERATED DEFLECTION FORCES THROUGH THE DISPLACED SOFT TISSUE. THE TECHNIQUE GUIDE RECOMMENDS THAT THE USER ¿CONFIRM THAT THE NAIL IS TIGHTLY CONNECTED TO THE INSERTION HANDLE, ESPECIALLY AFTER HAMMERING¿ AND SPECIFIES THE PROPER TECHNIQUE AND DEVICE MAINTENANCE (J3900-I). THEREFORE, THE METHOD OF USE WAS LIKELY THE CAUSE OF ANY MISALIGNMENT. HOWEVER, WITHOUT ADDITIONAL INFORMATION REGARDING THE MATING COMPONENTS, IT IS NOT POSSIBLE TO CONFIRM THIS WAS THE CAUSE OF THE NOTED FAILURE. THE DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE, THE DESIGN HISTORIES DID NOT IMPACT THE COMPLAINT CONDITION, AND THERE WERE NO NOTED FAILURES TO MEET SPECIFICATIONS. THEREFORE, THIS COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 TFN (TROCHANTERIC FIXATION NAIL) FOR A PROXIMAL FEMUR FRACTURE WAS PERFORMED INTRA-OPERATIVELY. THE SURGERY WAS PROCEEDING NORMALLY UNTIL THE SURGEON ATTEMPTED TO INSERT THE HELICAL BLADE THROUGH THE ALREADY IMPLANTED NAIL, IT WOULD NOT PASS THROUGH. THE SURGEON WAS UNABLE TO GUIDE THE BLADE THROUGH THE NAIL. THE SURGEON CONFIRMED THAT THE PROPER NAIL AND AIMING DEGREE WERE CORRECT. IT WAS IDENTIFIED THAT THERE WAS AN ISSUE WITH THE 130 DEGREES AIMING ARM, BLADE GUIDE SLEEVE, AND/OR INSERTION HANDLE. THE SURGEON WAS ABLE TO INSERT THE HELICAL BLADE WITHOUT THE AIMING ARM AND BLADE GUIDE SLEEVE. THERE WERE NO ISSUES WITH THE NAIL AND HELICAL BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. THERE WAS A TEN MINUTE TIME EXTENSION IN SURGERY. THIS COMPLAINT IS 1 OF 5 FOR COMPLAINT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663199 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 5501138

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR