BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL, TRI-FLAT 4, 2X340 MM

    MDR report key: 2100193 · Received May 13, 2011

    Report

    Report Number
    9610622-2011-00219
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    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 INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT UNDERWENT A TKA. THE SUPRACONDYLAR OF PT WAS FRACTURED. THE SURGEON USED TO T2 SUPRACONDYLAR NAIL FOR THE SURGERY. WHEN THE SURGEON DRILLED TO THE SECOND SCREW HOLE OF THE DISTAL SCREW HOLE OF THE NAIL, THE DRILL CONTACTED THE FEMORAL COMPONENT OF THE TKA AND THE DRILL BROKE. THE SURGEON REMOVED THE TIP OF BROKEN DRILL. THE SURGERY WAS COMPLETED WITHOUT FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL, TRI-FLAT 4, 2X340 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other