BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 4110838 · Received September 23, 2014

    Report

    Report Number
    2530088-2014-10281
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 2, 2014
    Report Date
    August 2, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR WAS REVIEWED AND REPAIR WORK. ONE HELICAL BLADE INSERTER WAS RETURNED FOR DAMAGED COMPONENT. THE RETURNED DEVICE WAS SCRAPPED AND NOT RETURNED TO SERVICE. ONE HELICAL BLADE INSERTER WAS RETURNED FOR BINDING. THE RETURNED DEVICE WAS SCRAPPED AND NOT RETURNED TO SERVICE. THIS REPAIR IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE IS BINDING NOT ALIGNMENT. THE QE ACCEPTED THE PARTS AS CONFORMS AFTER VERIFYING THE DIMENSIONS ARE WITHIN SPECIFICATION ON THE COMPARATOR. THE RELEVANCE OF THIS NONCONFORMANCE IS NOT ABLE TO BE DETERMINED AT THIS TIME. A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES ATTEMPTING TO RECREATE THE COMPLAINT CONDITION OVER TEN TIMES THE HELICAL BLADE REPEATEDLY ENDED UP IN THE APPROPRIATE FINAL POSITION WITH THE FLAT AREA OF THE BLADE POSITIONED VERTICALLY PARALLEL WITH THE AXIS OF THE CONNECTING SCREW BARREL. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE RETURNED HELICAL BLADE WAS RECEIVED WITH TWO GOUGES ON THE LEFT AND RIGHT SIDE OF THE RECESSED AREA WHERE IT IS MEANT TO MATE WITH THE HELICAL BLADE INSERTER. THE COMPLAINT CONDITION AND THE DAMAGE SUSTAINED BY THE HELICAL BLADE INDICATE THAT THE ROOT CAUSE OF THE COMPLAINT IS LIKELY DUE TO INCORRECTLY MATING THE BLADE WITH THE INSERTER. THE GOUGES FOUND ON EITHER SIDE OF THE RECESSED AREA OF THE BLADE WHICH MATES WITH THE INSERTER SEEM TO DIRECTLY CORRESPOND WITH DAMAGE WHICH WOULD OCCUR IF THE BLADE WAS USED WHILE BEING INCORRECTLY ASSEMBLED TO THE INSERTER. UPON INVESTIGATION IT WAS DETERMINED THAT TWO POSSIBLE REASONS WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION INCLUDE THE HELICAL BLADE NOT BEING CORRECTLY ASSEMBLED TO INSTRUMENTS AND SURGEON MISINTERPRETING HELICAL BLADE POSITION IN X-RAY. IT IS LIKELY THAT THE CAUSE FOR THE INCORRECT POSITIONING OF THE HELICAL BLADE WAS DUE TO IT INCORRECTLY BEING ASSEMBLED TO THE HELICAL BLADE INSERTER. THE DESIGN OF THE TOOLS USED TO INSERT THE HELICAL BLADE RESTRICTS THE MANNER IN WHICH THE BLADE CAN BE INSERTED, IN ORDER TO ENSURE THAT THE POSITIONING OF THE HELICAL BLADE DOES NOT COMPROMISE THE PATIENT POST-OPERATIVELY. HOWEVER, WHEN THE HELICAL BLADE IS ASSEMBLED TO THE INSERTER INCORRECTLY IT WILL CAUSE THE HELICAL BLADE TO BE POSITIONED THE WAY IT WAS IN THE COMPLAINT CONDITION. THE SCRATCHES ON THE SIDES OF THE BLADE ALSO INDICATE THAT IT WAS NOT ASSEMBLED TO THE INSERTER PROPERLY AND SUBSEQUENTLY WAS DAMAGED DURING INSERTION/EXTRACTION. CONSIDERING THE CIRCUMSTANCES SURROUNDING THE COMPLAINT AND SINCE THE COMPLAINT CONDITION COULD NOT BE RECREATED USING THE RETURNED PARTS, THE DEVICES ARE DETERMINED TO BE SUITABLE AND SAFE FOR THEIR INTENDED USE AND THE COMPLAINT CONDITION UNCONFIRMED. 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, DURING A PROCEDURE FOR THE IMPLANTATION OF TROCHANTERIC FIXATION NAIL (TFN), A HELICAL BLADE SEEMED TO BE MISALIGNED AFTER BEING INSERTED INTO THE NAIL. THE TFN AND HELICAL BLADE WERE INSERTED USING THE CONSTRUCT OF THE AIMING ARM, INSERTION HANDLE, GUIDE SLEEVE, WIRE GUIDE, COMPRESSION NUT AND BLADE INSERTER. ONCE THE HELICAL BLADE WAS INSERTED, IT WAS NOTED THAT THE THREADS SEEMED TO BE POSITIONED INCORRECTLY. RATHER THAN BEING POSITIONED TO THE SIDE, THEY WERE POSITIONED IN AN UPWARD FASHION. THE DECISION WAS MADE TO REMOVE THE BLADE AND A SCREW WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A DELAY OF FIFTEEN MINUTES NOTED IN THIS PROCEDURE. NO PATIENT HARM WAS REPORTED. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589719 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4576929

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR