BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM DRILL 25MM

    MDR report key: 3844181 · Received June 2, 2014

    Report

    Report Number
    0002249697-2014-02004
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMS THE MATERIAL WEAR OF THE DRILL WHICH IS DUE TO USAGE, LIKELY THROUGH CONTACT WITH A HARD MATERIAL. THE DAMAGED DEVICE WAS DISCOVERED DURING INSPECTION; THERE WAS NO SURGICAL PROCEDURE ASSOCIATED WITH THE REPORTED EVENT. THIS EVENT MEETS THE DEFINITION OF PREVENTIVE MAINTENANCE; NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    DURING THE IN-COMING INSPECTION BY DISTRIBUTION CENTER STUFF, THE SHAFT OF THE DEVICE WAS FOUND BENT AND THE BLADE EDGE OF THE DRILL BECAME WORN. AFTER REVIEWING THE SR, SHARPNESS OF THE DRILL IS BAD AT THE SAME OPERATION WHEN CAT# 2107-2200 WAS USED.

    Description of Event or Problem · 1

    DURING THE IN-COMING INSPECTION BY DISTRIBUTION CENTER STUFF, THE SHAFT OF THE DEVICE WAS FOUND BENT AND THE BLADE EDGE OF THE DRILL BECAME WORN. AFTER REVIEWING THE SR, SHARPNESS OF THE DRILL IS BAD AT THE SAME OPERATION WHEN CAT# 2107-2200 WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322425 4.0MM DRILL 25MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other