BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M CRIMP TOOL

    MDR report key: 2990825 · Received March 6, 2013

    Report

    Report Number
    0002249697-2013-00914
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION SHOWED THE DOWEL PIN WAS MISSING FROM THE RATCHET ASSEMBLY, AND THERE WAS NO SIGN OF A WELD. MATERIAL ANALYSIS CONCLUDED THAT THERE WAS NO EVIDENCE OF INTERFERENCE BETWEEN ON THE RATCHET ASSEMBLY HOLES EXAMINED. DIMENSIONAL ANALYSIS DETERMINED THAT THE LEVER PIN HOLE WAS OVERSIZED. THE EVENT WAS CONFIRMED. A DEVICE HISTORY REVIEW INDICATED THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO SIMILAR EVENTS FOR THE REPORTED LOT. THE INVESTIGATION CONCLUDED THAT THE DOWEL PIN COMING OUT OF THE RATCHET ASSEMBLY OF THE D/M CRIMP TOOL WAS CAUSED BY A MANUFACTURING NONCONFORMANCE. BASED UPON THE CONCLUSIONS OF THE VISUAL, MATERIAL, AND DIMENSIONAL ANALYSIS, IT WAS CONCLUDED THAT THE SUPPLIER, (B)(4), HAD NOT PERFORMED THE REQUIRED WELDING OPERATION ON THE RATCHET ASSEMBLY AND HAD MANUFACTURED THE LEVER PIN HOLE OVERSIZED WHICH BOTH LED TO THE PIN COMING OUT OF THE ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATCHET OF THE CRIMP TOOL WAS NOT FUNCTIONAL IN THA. THE SURGEON NOTICED THE PIN OF THE RATCHET WAS OFF AND PIN WAS NOT FOUND. SO, THE SURGEON CHECKED THE X-RAY AND THERE WAS NO PIN IN THE X-RAY. WE COULD NOT SPECIFY WHEN THE PIN WAS MISSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATCHET OF THE CRIMP TOOL WAS NOT FUNCTIONAL IN THA. THE SURGEON NOTICED THE PIN OF THE RATCHET WAS OFF AND PIN WAS NOT FOUND. SO, THE SURGEON CHECKED THE X-RAY AND THERE WAS NO PIN IN THE X-RAY. WE COULD NOT SPECIFY WHEN THE PIN WAS MISSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95799 D/M CRIMP TOOL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH RD6S186

    Patients

    Seq Age Sex Outcome Treatment
    1 Other