BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAI

    MDR report key: 2944978 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10037
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTING TO THIS COMPLAINT. VISUAL EVALUATION NOTED SEVERAL SIGNS OF INTENSE USE, SCRATCHES, STRESS MARKS AND DENTS ALL OVER THE INSTRUMENT AND A HEAVY DENT AT ONE OF THE CENTERING PINS. DURING FUNCTIONAL EVALUATION THE DEVICE DID TARGET AS REQUIRED AND NO DEVIATION TO THE SPECIFICATION WAS FOUND. THE INVESTIGATION DETERMINED THAT APPLYING EXTREME FORCES ONTO THE CONSTRUCTION DURING A PROCEDURE, WHICH CAN LEAD TO A MISALIGNMENT. THE EVALUATION FOUND THAT THE REPORTED CONDITION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING THE TFN PROCEDURE, DRILL BIT HIT THE FIXATION NAIL AS IT WAS NOT LINING UP CORRECTLY. SURGEON TRIED INSTRUMENTS FROM TWO DIFFERENT SETS INTERCHANGEABLY: 2 PROTECTION SLEEVES (357.386), 2 DRILL SLEEVES (357.389), 2 TROCARS (357.387), 2 OF 130 DEG AIMING ARMS (357.366) AND 2 INSERTION HANDLES (357.411). ALSO ONE OF THE HELICAL BLADE COUPLING SCREWS (357.377) WAS DEFORMED AND WOULD NOT ACCEPT THE HEXAGONAL FLEXIBLE SCREWDRIVER - SCREWDRIVER DID NOT ENGAGE THE HEXAGONAL RECESS OF THE SCREW. THE DEFORMED COUPLING SCREW WAS DISCARDED. THERE WAS NO PATIENT IMPACT; THE DOCTOR REALIZED THE TROCARS WERE GOING POSTERIOR AND GAVE THE JIG A GOOD PULL ANTERIOR. THIS ADDED ABOUT 20-30 MINUTES TO THE PROCEDURE. THIS COMPLAINT IS 4 OF 12 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43894 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAI HSB SYNTHES GMBH 5016996

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention