BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 3983607 · Received August 6, 2014

    Report

    Report Number
    2530088-2014-10207
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONE PART 357.377 WAS RECEIVED INTACT. THE KNURLED KNOB ON THE COUPLING SCREW CONTAINS SIGNIFICANT HAMMER MARKS. WORKING LENGTH HAS NUMEROUS ROLL MARKS FROM ROUTINE USE, AND THE DISTAL THREADS ARE UNDAMAGED. THE HELICAL BLADE INSERTER, AIMING ARM, AND COUPLING SCREW SHOW EXTENSIVE USAGE WITH NUMEROUS SCRATCHES AND HAMMER MARKS. THE BLADE GUIDE SLEEVE IS IN EXCELLENT CONDITION WITH MINIMAL SCRATCHING. THE INSTRUMENTS WERE ASSEMBLED WITH KNOWN GOOD INSTRUMENTS AVAILABLE IN THE COMPLAINT HANDING UNIT AND NO ISSUES WERE FOUND, THEREFORE THIS COMPLAINT IS UNCONFIRMED. THE DRAWINGS FOR WERE REVIEWED AND ARE DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE RETURNED INSTRUMENTS ARE PART OF THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN) AND THEIR PROPER USE AND MAINTENANCE IS ADDRESSED IN TECHNIQUE GUIDES. INSERTION OF THE HELICAL BLADE IS VERY TECHNIQUE DEPENDENT. BASED ON THE EVALUATION AND THE INABILITY TO REPLICATE THE COMPLAINT CONDITION, IT APPEARS THAT SOFT TISSUES MAY HAVE PLACED DEFLECTION FORCE ON THE INSTRUMENTS PREVENTING INSERTION OF THE HELICAL BLADE. BECAUSE OF THIS, THE 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. THIS COMPLAINT IS UNCONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE 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.

    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 DIAGNOSISIF 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 TROCHANTERIC FIXATION NAIL PROCEDURE, A 120 MM HELICAL BLADE WOULD NOT INSERT. IT WAS CATCHING ON THE NAIL; THE TIP ENDED UP BEING BENT AND WAS NOT IMPLANTED IN THE PATIENT. IT IS POSSIBLE THAT INCISION SITE FOR HELICAL BLADE WAS IN WRONG PLACE. SO THE INSERTION HANDLE WAS PULLED TO COMPENSATE THE SOFT TISSUE STRETCH AND GET THE CORRECT ANGLE. THE SOFT TISSUE PULLED THE COMPRESSION SLEEVE SO IT DID NOT LINE UP. A LAG SCREW WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A REPORTED SURGICAL DELAY OF TWO MINUTES AND THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS REPORTED AS FINE. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461958 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5491502

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR