BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE F. SOLID STEPDRILL

    MDR report key: 2472125 · Received February 23, 2012

    Report

    Report Number
    9610622-2012-00092
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. ASSOCIATE DEVICES ARE: 1806-3025 STEPDRILL FOR LAG SCREW LOT NUMBER K962096, 702634 LARGE AO COUPLING ASNIS III HALL FITTING LOT NUMBER P19584.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE DRILL WAS INSERTED INTO A DRILL SLEEVE THAT WAS NOT COMPATABLE WHICH CAUSED A COLD WELD OF THE PIECES. THE CHUCK WAS STUCK AFTER THE ATTEMPTED REMOVAL OF THE ITEMS AND THE ATTEMPTED SEPARATION. NO PROBLEMS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL SLEEVE F. SOLID STEPDRILL INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K928033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other