BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW, TIBIA 10 MM

    MDR report key: 2481780 · Received March 2, 2012

    Report

    Report Number
    9610622-2012-00110
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. IF ADDITIONAL INFO IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES 1822-1539S TIBIAL NAIL, STANDARD 15X390 MM, LOT# K165375. UNK PRODUCT - STRIKE PLATE, LOT# UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "AS SURGEON WAS TRYING TO INSERT THE 15 DIAMETER TIBIAL NAIL, HE REAMED TO A 20 BUT THE NAIL WOULD NOT GO DOWN. THE SURGEON THEN BEGAN HITTING THE TARGETER IN ALTERNATE POSITIONS TO TRY AND GET THE NAIL DOWN, AND PART OF THE NAIL HOLDING BOLT CAME OFF OF THE BOLT AND CAME DOWN THROUGH THE TOP OF THE NAIL. THE SURGEON BELIEVED THAT THE STRIKE PLATE WAS NOT ENGAGING PROPERLY. THE NAIL HAD TO BE REMOVED AND A NEW NAIL WAS IMPLANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAIL HOLDING SCREW, TIBIA 10 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K910462

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other