BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER RASP HANDLE

    MDR report key: 2000026 · Received February 3, 2011

    Report

    Report Number
    9616680-2011-00044
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT DURING SURGERY, THE SURGEON ATTEMPTED TO RELEASE THE HANDLE THAT RELEASES THE BRIDGE. HOWEVER, THE SURGEON STRUGGLED TO DO THIS. WHEN THE HANDLE WAS FINALLY RELEASED, THE SURGEON NOTICED THAT THE SPRING MECHANISM INSIDE THE HANDLE WAS DAMAGED. THE SALES REP FURTHER REPORTED THAT ONE OF THE PINS THAT HOLDS THE SPRING MECHANISM IN PLACE WAS LOST. IT WAS NOT KNOWN IF THE PIN HAD FALLEN INTO THE WOUND SITE. THEREFORE, THE SURGEON REQUESTED AN X-RAY BE PERFORMED AND IT WAS CONFIRMED THAT THE SCREW WAS NOT LEFT IN THE PT. THE SALES REP ADDED THAT THIS CAUSED NO SIGNIFICANT DELAY TO SURGERY AND NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS CORK NA GZ583656

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other