BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M REMOVAL CABLE CUTTER

    MDR report key: 3061589 · Received April 16, 2013

    Report

    Report Number
    0002249697-2013-01338
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF THE REPORTED DEVICE BECOMES AVAILABLE FOR INSPECTION, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DR (B)(6) WENT TO CUT A CABLE AND THE CABLE BROKE.

    Description of Event or Problem · 1

    DR. (B)(6) WENT TO CUT A CABLE AND THE CABLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163596 D/M REMOVAL CABLE CUTTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH R4A02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other