BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.2MM TROCAR 232MM

    MDR report key: 3082173 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11197
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH 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. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS, THE INSERTION HANDLE FROM THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. DURING THIS EVALUATION, THE RETURNED DEVICES WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED AN INSERTION HANDLE, CANNULATED CONNECTING SCREW, TROCHANTERIC FIXATION NAIL, HELICAL BLADE, WIRE GUIDE, AND BALL HEX SCREWDRIVER. THE WAS CONSTRUCT ASSEMBLED AND THE HELICAL BLADE ALIGNED AND PASSED THROUGH THE TFN AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE INSERTION HANDLE WAS NOT RETURNED FOR EVALUATION, HOWEVER A KNOWN GOOD INSERTION HANDLE ALONG WITH OTHER PARTS OF THE CONSTRUCT ENABLED AN ADEQUATE CONSTRUCT DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, WHILE INSERTING THE HELICAL BLADE THE SURGEON MENTIONED THAT THE HELICAL BLADE FELT LIKE IT WAS BINDING AGAINST THE NAIL AS THE SHOULDER OF THE HELICAL BLADE PASSED THROUGH THE NAIL. SURGEON BELIEVED THAT THE INSERTION INSTRUMENTS MAY HAVE BEEN BENT. SURGEON CONTINUED TO INSERT THE BLADE AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. PER ADDITIONAL INFORMATION RECEIVED, ALL HARDWARE WAS REMOVED ON (B)(6) 2012 DUE TO BROKEN NAIL. THIS IS 2 OF 2 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184098 3.2MM TROCAR 232MM FZX SYNTHES GMBH 2736850

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention