BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3083408 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10543
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    December 5, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICES WERE RETURNED FOR A PRODUCT DEVELOPMENT EVENT EVALUATION AND WERE SEVERELY DAMAGED FROM BEING STRUCK. THE ENTIRE CONSTRUCT OF RETURNED PARTS WAS ASSEMBLED WITH A NAIL AND ALIGNED WELL. THERE WERE NUMEROUS DEEP GOUGES FROM HAMMER STRIKES ON THE AIMING ARM AND INSERTION HANDLE, BUT NEITHER APPEARED BENT AND DID ALIGN PROPERLY. THE BLADE GUIDE SLEEVE (BSG) HAD DENTS ON THE TOP OF THE HEAD AND THERE WAS ONE VERY LARGE DENT ON THE BEVELED EDGE OF THE NUT THAT SNAPS INTO THE AIMING ARM. THE NUT THREADED EASILY UP AND DOWN THE ENTIRE LENGTH OF THE THREADED SHAFT AND SUCCESSFULLY ADVANCED AND RETRACTED THE BGS WHEN ASSEMBLED INTO THE AIMING ARM. THERE WAS SOME INCREASED DRAG AS THE NUT ADVANCED THE SLEEVE OVER THE LAST 5 THREADS. EXCEPT FOR THE NOTICEABLE DAMAGE FROM BEING STRUCK, THE PARTS ALL FUNCTIONED AS INTENDED. THE BREAKAGE OF THE ALIGNMENT INDICATOR HAS BEEN PREVIOUSLY ADDRESSED AND IS THE RESULT OF MISSING THE COUPLING SCREW AND INADVERTENTLY HITTING THE ALIGNMENT INDICATOR. THE PURPOSE OF THE INDICATOR IS TO CAPTURE THE GOLD HANDLE ON THE INSERTER. IF THE TOP SPINS FREELY IT IS STILL HELD IN PLACE AND DOES NOT FALL OFF OF THE HELICAL BLADE INSERTER, AND THEREFORE THE CASE CAN BE COMPLETED WITHOUT INCIDENT. THE AIMING ARM, COMPRESSION NUT, BLADE GUIDE SLEEVE, AND INSERTION HANDLE ALL HAD SIGNIFICANT DAMAGE FROM MISUSE, BUT STILL ALIGNED AND FUNCTIONED WELL WHEN ASSEMBLED WITH MATING IMPLANTS. THIS COMPLAINT IS INVALID FROM A DESIGN STANDPOINT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL FEMUR HIP FRACTURE PROCEDURE, WHILE REMOVING THE INSTRUMENTS AFTER THE NAIL AND HELICAL BLADE WERE INSERTED, THE KNOB ON THE HELICAL BLADE COUPLING SCREW BROKE OFF. THE SURGEON COULD NOT UNSCREW THE HELICAL BLADE COUPLING SCREW FROM THE HELICAL BLADE THAT WAS IMPLANTED INTO THE FEMORAL HEAD. THE SURGEON WAS ALSO UNABLE TO RELEASE THE HELICAL BLADE INSERTER FROM THE AIMING ARM. THE SURGEON TRIED BACKING IT OUT BY MALLETING THE INSTRUMENTS. THE DEVICES WOULD NOT RELEASE AND WOULD NOT SEPARATE. THE DISTAL END OF THE HELICAL BLADE INSERTER BROKE AND THE AIMING ARM WAS DAMAGED AND MISALIGNED FROM THE SURGEON MALLETING THE DEVICES. THE SURGEON THEN USED THE SCREW REMOVAL SET TO BACK OUT THE HELICAL BLADE COUPLING SCREW FROM THE IMPLANTED HELICAL BLADE AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO HARM TO PATIENT. THIS IS 3 OF 3 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185064 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 5643194

    Patients

    Seq Age Sex Outcome Treatment
    1