BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON AR FEMORAL ALIGNMENT GUIDE

    MDR report key: 1800768 · Received August 4, 2010

    Report

    Report Number
    2249697-2010-00996
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: VISUAL INSPECTION INDICATED THAT ONE SCREW ON THE DEVICE WAS BACKED OUT PAST THE END OF THE THREADED PORTION AND WAS SEIZED AND STRIPPED. IT APPEARED AS IF THERE WAS AN ATTEMPT TO REMOVE THE SCREW. THE SCREW ON THE OPPOSITE SIDE WAS STILL FUNCTIONAL. THE INVESTIGATION CONCLUDED THAT THE SCREW WAS BACKED OUT TOO FAR, LIKELY WITH THE USE OF LARGE AMOUNTS OF TORQUE. THE ENDS OF THE SCREWS ARE NOT THREADED AND ARE PERMANENTLY INSTALLED DURING MANUFACTURING. THE THREADS WILL STRIP WITHIN THE GUIDE IF ATTEMPTS ARE MADE TO FULLY LOOSEN THE SCREW. THE SCREW COULD NOT BE RE-ENGAGED BY HAND WITH AN ALLEN KEY ON THIS DEVICE, INDICATING THAT THE SCREW HAD SEIZED DUE TO THE THREADS BEING STRIPPED WITHIN THE GUIDE BODY. THE DEVICE IS LABELED 'NON-REMOVABLE SCREWS'. THE STRYKER SALES REP MUST BE ADVISE THE USER NOT TO DISASSEMBLE THIS DEVICE AND FOLLOW GENERAL CLEANING AND MAINTENANCE INSTRUCTIONS FOR INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SCREWS STRIP. FAULT OF THE INSTRUMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON AR FEMORAL ALIGNMENT GUIDE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA P1L50

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other