BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" DRILL W/O STOP - 2/PKG

    MDR report key: 1940998 · Received December 7, 2010

    Report

    Report Number
    2249697-2010-01669
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL INSPECTION INDICATED THE RETURNED DRILL HAS FRACTURED. THE FRACTURED POINT IS LOCATED AT THE TRANSITION POINT FROM SOLID BAR TO THE FLUTES. THE 1/8" DRILL W/O STOP IS MADE OF 17-4 PH STAINLESS STEEL WITH MINIMUM HARDNESS HRC 38. THE FRACTURE SURFACE WAS EXAMINED UNDER AN OPTICAL MICROSCOPE AT 20X MAGNIFICATION. THE EXAMINATION REVEALED THAT THE FRACTURE HAD OCCURRED AS A RESULT OF A BENDING OVERLOAD AS OPPOSED TO A TORSIONAL OVERLOAD, SUGGESTING USER MISUSE. THE INVESTIGATION CONCLUDED THAT THE DRILL WAS LIKELY SUBJECTED TO EXCESSIVE BENDING FORCES DUE TO EXCESSIVE ANGULATION DURING DRILLING. THE DRILL IS NOT INTENDED TO PERFORM UNDER EXCESSIVE ANGULATION AND LOADING DURING USE. THIS EVENT IS BELIEVED TO BE RELATED TO USER MISUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE TKA, THE SURGEON WAS DRILLING THE PT TIBIA TO FIX A BASEPLATE, THE 1/8" DRILL WAS BROKEN. THE FRAGMENTS WAS REMOVED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1/8" DRILL W/O STOP - 2/PKG INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other