BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM

    MDR report key: 3020070 · Received March 25, 2013

    Report

    Report Number
    0009610622-2013-00162
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF THE INVESTIGATION IT WAS DETERMINED THAT THIS DEVICE IS CONCOMITANT. DID NOT CAUSE OR CONTRIBUTE TO THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, THE REPORTING DECISION WILL BE REEVALUATED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 GTN SURGERY, THE SURGEON DRILLED THE PROXIMAL SCREW HOLE OF THE NAIL BY THE 4.2MM DIAMETER DRILL. HOWEVER, THE DRILL BIT CONTACTED THE NAIL AND THE DRILL BIT BROKE. THEREFORE THE SURGEON REMOVED THE BROKEN PIECE FROM THE PATIENT BONE. AFTERWARDS, THE SURGEON INSERTED SCREW IN TRANSVERSE SCREW HOLE, AND COMPLETED THE OPERATION.

    Description of Event or Problem · 1

    DURING T2 GTN SURGERY, THE SURGEON DRILLED THE PROXIMAL SCREW HOLE OF THE NAIL BY THE 4.2MM DIAMETER DRILL. HOWEVER, THE DRILL BIT CONTACTED THE NAIL AND THE DRILL BIT BROKE. THEREFORE, THE SURGEON REMOVED THE BROKEN PIECE FROM THE PATIENT BONE. AFTERWARDS, THE SURGEON INSERTED SCREW IN TRANSVERSE SCREW HOLE, AND COMPLETED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122597 DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K394957

    Patients

    Seq Age Sex Outcome Treatment
    1