BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK ROD W/ BASO4, CURVED, 5.5MM X 45 MM

    MDR report key: 4844180 · Received June 15, 2015

    Report

    Report Number
    1526439-2015-10548
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE VIPER2 PEEK 5.5X45MM LORDOTIC ROD (PRODUCT CODE: 1867-82-045, LOT NUMBER: 5102443) WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU). THE ROD WAS RETURNED BROKEN INTO TWO SEPARATE PIECES AND SUBSEQUENTLY SUBMITTED FOR FRACTURE ANALYSIS. FRACTURE ANALYSIS WAS PERFORMED TO INVESTIGATE THE FRACTURE OF THE PEEK ROD. THE FRACTURED ROD SHOWS SIGNIFICANT WHITE DISCOLORING AROUND THE FRACTURE SITE DUE TO HIGH BENDING STRESSES. THE FRACTURED SURFACES OF THE RODS EACH EXHIBIT PLASTIC DEFORMATION CONSISTENT WITH OVER LOAD BENDING FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. A ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. THE RESULTS OF FRACTURE ANALYSIS HAVE DETERMINED THAT A PROBABLE ROOT CAUSE MAY BE OVER LOAD BENDING FAILURE DUE TO UNEXPECTEDLY HIGH FORCES PLACED ON THE ROD. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DR (B)(6) HAD PLACED ALL THE SCREWS (4) AND HAD MOVE TO THE NEXT STEP IN THE OPERATION WHICH WAS PLACING THE RODS AND TO FINAL TIGHTEN THE CONSTRUCT. AS HE FINAL TIGHTENED THE SECOND SCREW CAP USING THE CORRECT INSTRUMENT, THE ROD SNAPPED IN HALF. HE SAID THAT IT WAS UNACCEPTABLE AND THAT WE SHOULD PACK THE PEEK RODS IN STERILE PACKAGING, AS THE MATERIAL WEAKENS AFTER SO MUCH AUTOCLAVING. I AGREED WITH THE SURGEON AND HE WANTS TO KNOW THE CYCLE AMOUNT FOR AUTOCLAVING AND THE IMPACT IT HAS ON THE ACTUAL MATERIAL (HOW MANY TIMES IT CAN GO THROUGH THE AUTOCLAVE.) I WILL ALSO SEND THIS PRODUCT TO (B)(6) TO BE TESTED. I TOOK THE SNAPPED ROD FROM THE SURGEON AND WASHED IT IN PEROXIDE THEN STERI PEALED THE PRODUCT. WE FINISHED LATE, SO I DID THE PRODUCT COMPLAINT THE VERY NEXT MORNING. I ALSO INFORMED MY SALES MANAGER (B)(6)) AS WELL AS OUR PRODUCT MANAGER ((B)(6)). I TOLD THE DR WE WILL GIVE HIM A REPORT AS SOON AS WE HAVE INSPECTED THE PRODUCT AND ALSO GIVE HIM FEEDBACK AS TO THE POSSIBILITY ON PACKING THE RODS IN STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388831 PEEK ROD W/ BASO4, CURVED, 5.5MM X 45 MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 5102443

    Patients

    Seq Age Sex Outcome Treatment
    1