BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPDRILL FOR LAG SCREW

    MDR report key: 1884557 · Received October 21, 2010

    Report

    Report Number
    9610622-2010-00446
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL SURGERY, TO INSERT LAG SCREW AFTER NAIL HAD BEEN INSERTED, THE SURGEON INSERTED GUIDE WIRE. THE SURGEON DRILLED THE HOLE FOR THE LAG SCREW HOLE OF THE NAIL USING THE CANNULATED STEP DRILL. HOWEVER, THE STEP DRILL WAS CONTACTING THE EDGE OF LAG SCREW HOLE OF THE NAIL. THE SURGEON DRILLED THE PROXIMAL LAG SCREW HOLE IN FIRST. TIP OF THE STEP DRILL WAS BROKEN WHEN THE SURGEON DID THE PROXIMAL LAG SCREW HOLE DRILLING. THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED. THE SURGEON CHANGED THE LOCKING MODE TO THE ANTEGRADE MODE. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEPDRILL FOR LAG SCREW INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K757474

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other