BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY TRIDENT HEX DRIVER FOR USE WITH CURVED CUP IMPACTOR PER FILE H1385

    MDR report key: 3140942 · Received June 3, 2013

    Report

    Report Number
    0002249697-2013-01842
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A NON FUNCTIONAL SPECIALTY DRIVER SHAFT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: MATERIAL DEFORMATION AND WEAR WAS OBSERVED ON THE THREADED PIN¿S INTERNAL HEX SOCKET AND THE HEX DRIVER HEAD. THE DAMAGE WAS CONSISTENT WITH IN-SERVICE USE. THE EDS RESULT FOR THE HEX DRIVER RESULTED IN A COMPOSITION CONSISTENT WITH CUSTOM 455 STAINLESS STEEL ALLOY. ROCKWELL HARDNESS TEST DATA RESULTS FOR THE HEX DRIVER WERE CONSISTENT WITH DESIGN REQUIREMENTS. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED BECAUSE NO RECORDS WERE PROVIDED. ADDITIONALLY, THERE IS NO INDICATION THAT PATIENT FACTORS CONTRIBUTED TO THE EVENT. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THERE WAS MATERIAL DEFORMATION AND WEAR, WHICH IS DAMAGE CONSISTENT WITH IN-SERVICE USE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE IMPACTOR WILL NOT RELEASE THE SHELL. INSTRUMENT IS STRIPPED. NO ADVERSE CONSEQUENCE TO PATIENT OR USER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE IMPACTOR WILL NOT RELEASE THE SHELL. INSTRUMENT IS STRIPPED. NO ADVERSE CONSEQUENCE TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244094 SPECIALTY TRIDENT HEX DRIVER FOR USE WITH CURVED CUP IMPACTOR PER FILE H1385 INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH F6V15306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other