BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE

    MDR report key: 3252770 · Received July 29, 2013

    Report

    Report Number
    0002249697-2013-02474
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS UPDATED BASED ON RETURNED DEVICE. AN EVENT REGARDING NOT LOCKING INVOLVING A RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. FUNCTIONAL TEST INDICATED THAT THE RETURNED DEVICE IS FUNCTIONAL AS ACCOLADE I AND ACCOLADE I BROACHES REMAINED FIRMLY LATCHED IN DURING BOTH RASP IMPACTION AND EXTRACTION. A MALLET WAS USED TO HIT THE HANDLE ON DIFFERENT LOCATION AND WAS NOT ABLE TO RELEASE THE LOCKED LEVER OR THE BROACHES USED FOR THE TEST. DEVICE HISTORY REVIEW INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATES PREVIOUS EVENTS REGARDING LOOSENING AND FAILURE OF A RASP HANDLE LOCKING MECHANISM. THE EVENT WAS NOT CONFIRMED AS THE FUNCTIONAL ANALYSIS REVEALED THE LATCH HANDLE ASSEMBLY REMAINED FIRMLY LATCHED IN. THE INVESTIGATION CONCLUDED THAT THE RETURNED BROACH HANDLE WAS FUNCTIONAL; NO MANUFACTURING DEFECTS WERE IDENTIFIED ON THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SPRING IN DOUBLE OFFSET RASP HANDLE MALFUNCTIONED. SURGEON HAD TO USE HAND TO HOLD LEVER ARM DOWN TO LOCK RASP. NO OTHER CONSEQUENCE.

    Description of Event or Problem · 1

    SPRING IN DOUBLE OFFSET RASP HANDLE MALFUNCTIONED. SURGEON HAD TO USE HAND TO HOLD LEVER ARM DOWN TO LOCK RASP. NO OTHER CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354006 RIGHT - NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH P4T55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other