BEUDAMED
    FDA Adverse Event Summary report: N

    SNAP CLAMP ASSEMBLY

    MDR report key: 3970704 · Received April 1, 2014

    Report

    Report Number
    2125289-2014-00001
    Date Received
    April 1, 2014
    Report Date
    March 12, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP OH/USA
    Product Code
    GAD
    PMA / PMN Number
    K842762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY REPORT. RESULT: FAILURE ANALYSIS - UPON RECEIVING THE ASSEMBLY, IT WAS OBSERVED TO HAVE NO EXTERNAL DAMAGE OR MISSING PIECES, BUT THAT THE HANDLE WOULD NO LONGER LOCK. AFTER DISASSEMBLING THE PRODUCT, IT WAS CLEAR THAT THE CAUSE OF THE LOCK MALFUNCTION WAS A BROKEN CAM SHAFT CAP. IT IS CONFIRMED THAT A BROKEN PORTION OF THE COMPONENT IS MISSING, WITH APPROX HALF OF IT ACCOUNTED FOR. THE MISSING COMPONENT IS MADE FROM VIRGIN PEEK 1000 MATERIAL. THE CAM SHAFT CAP WAS FOUND TO BE BROKEN DOWN THE MIDDLE WITH THE STEM PORTION REMAINING IN THE CAM SHAFT BASE. ONE HALF OF THE UPPER PORTION THAT CONTACTS WITH THE CAM WAS MISSING. MOST LIKELY, THE MISSING MATERIAL FELL OUT THROUGH THE CAM SHAFT OPENING. IT CANNOT BE CONFIRMED IF THE MISSING PORTION OF THE SHAFT CAP IS IN ONE OR MULTIPLE PIECES. DEVICE HISTORY REVIEW - NO ABNORMALITIES RELATE TO REPORTED INCIDENT FOUND NOR WERE THERE ANY VARIANCES, MRR'S OR REWORKS ASSOCIATED WITH THIS LOT/WORK ORDER NUMBER. NO SERVICE HISTORY ON FILE. CONCLUSION: WE ARE UNABLE TO CONFIRM THE END USERS EXPERIENCE THAT "A SMALL PART FROM THE 4040 HAS GOT IN THE PT" HOWEVER, THE SNAP CLAMP WAS FOUND TO HAVE A BROKEN COMPONENT WITH A PORTION FOUND TO BE MISSING UPON EVAL. THERE ARE TWO REASONS FOR THIS FAILURE. THE FIRST REASON IS DUE TO THE RADIUS SIZE BETWEEN THE HEAD AND STEM PORTION OF THE CAM SHAFT CAP BEING TOO SMALL CAUSING A WEAK POINT AT THIS INTERSECTION WHERE A FRACTURE COULD OCCUR. THE SECOND REASON WAS THAT DEFORMATION MARKS ON THE SAME RADIUS CAUSED BY THE CAM SHAFT BASE GEOMETRY COULD ALSO CREATE WEAK POINT FOR A POTENTIAL FRACTURE. BOTH OF THESE COMPONENTS HAVE HAD DESIGN CHANGES IMPLEMENTED TO RESOLVE THESE ISSUES INCLUDING CHANGING THE CAM SHAFT CAP RADIUS. THESE COMPONENTS WERE UPDATED TO THE NEW DESIGN REVISIONS. THIS ASSEMBLY HAD NOT RECEIVED ANY REPAIRS IN THE PAST. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED, INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE SURGEONS BELIEVE THAT A SMALL PART FROM THE 4040 FELL INTO THE PT. ON (B)(6) 2014, DEALER REPORTS AT THE COMPLETION OF A REDO BRICKER PROCEDURE (URINARY DIVERSION), THE SURGEON NOTICED THE PIECE MISSING WHEN REMOVING THE RETRACTOR. NO X-RAY WAS TAKEN, NO REASON GIVEN EXCEPT "THE SURGEON ABSTAINED THE X-RAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193464 SNAP CLAMP ASSEMBLY SURGICAL RETRACTOR GAD INTEGRA LIFESCIENCES CORP OH/USA M35979

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR