BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3057113 · Received April 15, 2013

    Report

    Report Number
    8030965-2013-01648
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE RETURNED AIMING ARM (PART#357.366, LOT#3240024) WAS MANUFACTURED IN SEPTEMBER 2009 AND IS OVER 3 YEARS OLD. THE RETURNED INSERTION HANDLE (PART#357.411, LOT#3328R13) WAS MANUFACTURED IN MAY 2009 AND IS OVER 3 YEARS OLD. THE RETURNED PROTECTION SLEEVE (PART#357.386, LOT#6060096) WAS MANUFACTURED IN MARCH 2009 AND IS OVER 4 YEARS OLD. THE RETURNED DRILL SLEEVE (PART#357.389, LOT#6125948) WAS MANUFACTURED IN JUNE 2009 AND IS OVER 3 YEARS OLD. DURING THIS EVALUATION, THE RETURNED INSERTION HANDLE, AIMING ARM, PROTECTION SLEEVE AND DRILL SLEEVE FROM THIS COMPLAINT 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 A SHORT TROCHANTERIC FIXATION NAIL (10MM X 130 DEG. X 170MM) (PART#456.315, LOT#6700338), CANNULATED CONNECTING SCREW (PART#357.397, LOT#6606047), 4.0MM TROCAR (PART#357.387, LOT#4588829) AND BALL HEX SCREWDRIVER (PART#357.515, LOT#4936924). THE CONSTRUCT ASSEMBLED, THE 4.0MM TROCAR AND RETURNED DRILL SLEEVE ALIGNED WITH THE SHORT TFN DISTAL HOLE AS INTENDED. THE COMPLAINT CONDITION OF MISSING THE DISTAL NAIL HOLE COULD NOT BE REPLICATED DURING THIS EVALUATION. THE RETURNED INSERTION HANDLE, AIMING ARM, PROTECTION SLEEVE AND DRILL SLEEVE WERE ASSEMBLED WITH KNOWN GOOD PARTS OF THE CONSTRUCT AND ENABLED AN ADEQUATE CONSTRUCT DURING THIS EVALUATION. THE DRILL SLEEVE ALIGNED WITH THE TFN DISTAL HOLE AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SYNTHES (B)(4) MANUFACTURED THE 130 DEGREE AIMING ARM FOR TROCHANTERIC FIXATION NAILS, PART 357.366, AND LOT NUMBER 3240024. THE PARTS CONFORMED PER SYNTHES PURCHASE ORDER (B)(4), DATED (B)(4) 2009. THERE WERE NO NON CONFORMANCES OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A RIGHT HIP INTERTROCHANTERIC NAIL FIXATION PROCEDURE ON (B)(6) 2013, THE SURGEON UTILIZED THE AIMING GUIDE ASSEMBLY AND ATTEMPTED TO IMPLANT THE DISTAL LOCKING SCREW AND MISSED THE NAIL HOLE. THE SURGEON ATTEMPTED A FEW MORE TIMES WHILE USING THE GUIDE AS WELL AS A GUIDE FROM ANOTHER SET BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE SURGEON IMPLANTED THE DISTAL LOCKING SCREW MANUALLY WITHOUT THE GUIDE AND COMPLETED THE PROCEDURE. THE PROCEDURE WAS DELAYED OVER 15 MINUTES. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160252 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES GMBH 3240024

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention