BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 95MM-STERILE

    MDR report key: 3195511 · Received June 28, 2013

    Report

    Report Number
    3003506883-2013-00283
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PART RECEIVED INTACT AND IS EXCELLENT CONDITION EXCEPT FOR A NOTCH IN ONE OF THE FLUTES APPROXIMATELY 1MM DEEP. THIS NOTCH MAY HAVE OCCURRED DURING THE IMPLANTATION PROCEDURE WHEN THE BLADE IMPACTED THE NAIL AS NOTED ABOVE IN THE DESCRIPTION SECTION. ALL MANUFACTURING DIMENSIONS ARE WITHIN STATED PARAMETERS.

    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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. 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 2 OF 8 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295392 11.0MM TI HELICAL BLADE 95MM-STERILE HSB SYNTHES ELMIRA 7050256

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention