BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 3173572 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03351
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS ATTEMPTED, BUT THE LOT NUMBER DOES NOT CORRESPOND TO THE PART NUMBER.

    Additional Manufacturer Narrative · 1

    AN INCORRECT LOT NUMBER WAS PREVIOUSLY RECEIVED FOR WHICH A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. SINCE THE INITIAL MEDWATCH WAS SUBMITTED, THE CORRECT LOT NUMBER WAS OBTAINED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE WAS MANUFACTURED IN SEPTEMBER 2008 AND IS OVER 4 YEARS OLD. THE DRILL BIT IS FRACTURED ON THE DISTAL END WITH THE FRACTURE SLIGHTLY ANGLED (APPROXIMATELY 30 DEGREES). THIS DRILL BIT IS USED TO CREATE A PATH FOR THE TROCHANTERIC FIXATION NAIL HELICAL BLADE OR SCREW. THESE DRILL BITS ARE RECOMMENDED TO BE SINGLE USE, BUT IT IS UP TO THE HOSPITAL¿S DISCRETION IF THEY WOULD LIKE TO USE IT MORE THAN ONCE. THE INSERT PACKAGED WITH THE DEVICE REVIEWS THE INSPECTION STEPS TO ENSURE THERE ARE NO DULL OR DAMAGED EDGES, IF THERE ARE IT SHOULD BE REPLACED. THIS STEPPED DRILL BIT IS MADE FROM HEAT TREATED 440A SS MATERIAL, WHICH IS A COMMON MATERIAL USED IN THIS TYPE OF DRILLING APPLICATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRACTURE RESULTING FROM A GUN SHOT WAS BEING REPAIRED BY A TROCHANTERIC FIXATION NAILING WHEN THE SURGEON AND SURGICAL TEAM LOST TRACTION ON THE LEG, CAUSING THE GUIDEWIRE TO EXPERIENCE A LOT OF TENSION. THE WIRE WAS SUBSEQUENTLY AIMED IN A DIFFERENT DIRECTION THAN INTENDED. A DRILL BIT THEN BROKE WITHIN THE NAIL AND WAS RETRIEVED. ANOTHER DRILL BIT BROKE OFF INSIDE THE FEMORAL HEAD AND PART OF IT WAS LEFT IMBEDDED THEREIN. THIS BLOCKED THE PASSAGE OF THE HELICAL BLADE THROUGH THE FEMORAL HEAD, SO THE SURGEON OPTED FOR AN ANTEGRADE NAIL INSTEAD. THIS ADDED APPROXIMATELY ONE HOUR ONTO THE TOTAL SURGICAL TIME. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273699 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM HTO SYNTHES USA US93802

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR