BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3195515 · Received June 28, 2013

    Report

    Report Number
    2530088-2013-00992
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR WAS REVIEWED AND REPAIR WAS FOUND ON P/N 357.372 WORK ORDER 1422117 LOT 4815961. ONE HELICAL BLADE INSERTER WAS RETURNED FOR DAMAGED COMPONENT. THE DEVICE WAS REPAIRED, INSPECTED AND RELEASED ON 4/17/2007. THE RELEVANCE OF THIS REPAIR IS NOT ABLE TO BE DETERMINED. MRR 50243 WAS FOUND ON P/N 357.372.3.3 LOT 4755229 FOR BURRS. THE NONCONFORMING PARTS WERE REWORKED, INSPECTED AND ACCEPTED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE IT IS FOR A VISUAL ISSUE ON A COMPONENT THAT WOULD NOT AFFECT ALIGNMENT. MRR 44884 WAS FOUND ON RAW MATERIAL P/N 31015 LOT 4623700 FOR ØA UNDERSIZE. THE MATERIAL WAS ACCEPTED USE AS IS BY THE ME BECAUSE THE UNDERSIZE RAW MATERIAL CONDITION WILL NOT AFFECT THE PERFORMANCE OF THE MACHINE OR PART QUALITY. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS ON RAW MATERIAL USED TO MAKE THE HANDLE COMPONENT NOT FINISHED PRODUCT. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED AIMING ARM (PART 357.366, LOT 3360761) WAS MANUFACTURED IN MARCH 2010 AND IS OVER 3 YEARS OLD. THE RETURNED BLADE GUIDE SLEEVE (PART 357.369, LOT 5060068) WAS MANUFACTURED IN NOVEMBER 2005 AND IS OVER 7 YEARS OLD. THE RETURNED BUTTRESS/COMPRESSION NUT (PART 357.371, LOT 4546699) WAS MANUFACTURED IN MAY 2003 AND IS OVER 10 YEARS OLD. THE RETURNED HELICAL BLADE COUPLING SCREW (PART 357.377, LOT 4728595) WAS MANUFACTURED IN JULY 2004 AND IS APPROXIMATELY 9 YEARS OLD. THE RETURNED HELICAL BLADE INSERTER (PART 357.372, LOT 4815961) WAS MANUFACTURED IN JULY 2004 AND IS APPROXIMATELY 9 YEARS OLD. THE RETURNED HELICAL BLADE (PART 456.304, LOT 7050256) WAS MANUFACTURED IN OCTOBER 2012 AND IS LESS THAN 1 YEAR OLD. THE RETURNED SHORT TROCHANTERIC FIXATION NAIL (PART 456.315, LOT 7291560) WAS MANUFACTURED IN MARCH 2013 AND IS LESS THAN A YEAR OLD. THE RETURNED INSERTION HANDLE (PART 357.411, LOT 6286402) WAS MANUFACTURED IN APRIL 2010 AND IS OVER 3 YEARS OLD. DURING THIS EVALUATION, THE RETURNED DEVICES FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE HELICAL BLADE WITH RESPECT TO THE TROCHANTERIC FIXATION NAIL. THE MATING KNOWN GOOD PARTS INCLUDED A CANNULATED CONNECTING SCREW AND BALL HEX SCREWDRIVER. THE CONSTRUCT ASSEMBLED AND THE RETURNED HELICAL BLADE ALIGNED AND ENTERED THE PROXIMAL LOCKING HOLE IN THE RETURNED TROCHANTERIC FIXATION NAIL ON EACH ATTEMPT AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE TROCHANTERIC FIXATION NAIL RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION AS LESS SEVERE. SPECIFICALLY, THE RISK ASSOCIATED WITH THE 3RD HAZARD LISTED UNDER INSTRUMENTATION ON ASSEMBLY (INSTRUMENTATION DOES NOT TARGET THE IMPLANTS (BOTH PROXIMAL AND DISTAL LOCKING) DUE TO DIMENSIONAL MISMATCH OF HANDLE, AIMING ARM, COMPONENTS OR DAMAGED PRIOR TO USE IS ASSESSED AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN IMPROBABLE PROBABILITY OF OCCURRENCE 1 WITH POSSIBLE HARM LISTED AS CANNOT USE SYSTEM FOR SURGERY. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE CONSTRUCT ASSEMBLED AND THE RETURNED HELICAL BLADE ALIGNED AND ENTERED THE PROXIMAL LOCKING HOLE IN THE RETURNED TROCHANTERIC FIXATION NAIL ON EACH ATTEMPT AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING THE SHORT TROCHANTERIC FIXATION NAIL AND HELICAL BLADE; THE NAIL WAS IMPLANTED BUT THE BLADE WOULD NOT GO THROUGH THE NAIL. IT WAS IMPACTING THE LATERAL EDGE OF THE HOLE IN THE NAIL. THE SURGEON REMOVED THE NAIL AND BLADE, CHECKED AND RETIGHTENED ALL INSTRUMENTATION, RE-CHECKED ANGULATION OF THE AIMING ARM AND INSERTION HANDLE. THE LOCK IN MECHANISM WAS NOT DEPLOYED. SURGICAL DELAY TIME OF 40 MINUTES WAS REPORTED. THIS REPORT IS 3 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296365 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 4815961

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention