BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3074925 · Received April 24, 2013

    Report

    Report Number
    8030965-2013-01913
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE RETURNED AIMING ARM PART 357.366, LOT 3240024 WAS MANUFACTURED IN SEPTEMBER 2009 AND IS OVER 3 YEARS OLD. THE RETURNED BLADE GUIDE SLEEVE PART 357.369, LOT 4764115 WAS MANUFACTURED IN JUNE 2004 AND IS OVER 8 YEARS OLD. DURING THIS EVALUATION, THE RETURNED AIMING ARM AND BLADE GUIDE SLEEVE FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION OF THE RETURNED DEVICES. THE CONSTRUCT ASSEMBLED AND THE RETURNED DEVICES ALIGNED AND ENGAGED AND DISENGAGED ON EACH ATTEMPT AS INTENDED. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING AN ORIF-LEFT HIP FRACTURE SURGERY ON (B)(6) 2013, WHILE INSERTING THE HELICAL BLADE, THE SURGEON HAD ISSUES WITH THE BLADE GUIDE SLEEVE AND AIMING ARM. THE BLADE GUIDE OUTER SLEEVE WOULD NOT SLIDE OVER INNER SLEEVE. IN ADDITION, THE AIMING ARM BUTTON WOULD NOT WORK CORRECTLY. SURGEON REMOVED THE INSTRUMENTS AN EXPLANTED THE NAIL AND BLADE. ALL ITEMS WERE TESTED ON THE BACK TABLE WITH NO PROBLEM. SURGEON RE-IMPLANTED THE NAIL AND BLADE WITH NO ADDITIONAL ISSUES. DUE TO THIS EVENT AN ADDITIONAL 30 MINUTES WAS ADDED TO THE SURGERY TIME. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177694 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES GMBH 3240024

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Required Intervention