BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 3972880 · Received August 1, 2014

    Report

    Report Number
    2520274-2014-12949
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED AND NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    ADDITIONAL NARRATIVE: A SERVICE HISTORY EVAL WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE NUT WAS STRIPPED OUT. THE REPAIR TECHNICIAN REPORTED THREADS STRIPPED AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: STOP SCREW, HEX SCREW M7 X 0.75. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER ON 18-JUL-2014. THE EVALUATION WAS CONFIRMED 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

    IT WAS REPORTED BY THE SERVICE AND REPAIR DEPARTMENT THAT ONE OF THE NUTS IS STRIPPED OUT ON THE SYNFRAME HALF RING. COMPLAINT ISSUE HAPPENED DURING CASE. THE SURGEON WAS ABLE TO COMPLETE PROCEDURE. REPORTEDLY, THERE WERE METAL SHAVINGS COMING FROM THE STRIPPED AREA. THIS EVENT DID NOT CONTRIBUTE TO A DEATH OR INJURY, WHETHER THE DEVICE WAS MISUSED OR NOT. IT WAS ALSO REPORTED ON THAT PATIENT WAS ADMITTED FOR SPINAL FUSION ANTERIOR L5-S1 AND SPINAL FUSION POSTERIOR L5-S1. THE EVENT HAPPENED INTRAOPERATIVELY ON INITIAL SURGERY. ADDITIONALLY, THE SCRUB TECHNICIAN REPORTED THAT ON A SEPARATE MAYO STAND, THE SYNFRAME RING WAS PUT TOGETHER. WHEN ADJUSTING AND TIGHTENING THE SCREWS TO COMPLETE THE RING, METAL FILINGS WERE NOTICED. THE SCREWS WERE DIFFICULT TO THREAD AND WAS TAKEN APART, RE-EXAMINED THE HALF-RINGS, RINSED THE FILINGS AWAY. I ATTEMPT TO PUT THE RING TOGETHER AGAIN SUCCESSFULLY THIS TIME WITH NO METAL FILINGS NOTED DURING THE TIGHTENING OF THE SCREWS. AFTER RINSING THE RING ONCE AGAIN, CHANGING OF THE TECHS OUTER GLOVES AND REPLACING THE MAYO STAND COVER; THE TECH WAS CONFIDENT THERE WERE NO METAL FILINGS PRESENT. THE ISSUE WAS REPORTED TO THE COORDINATOR POST-OP AND THE SYNFRAME WAS REMOVED FROM SERVICE. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451083 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR LXH SYNTHES USA 8251723

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR