BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME HALF RING

    MDR report key: 4247707 · Received November 13, 2014

    Report

    Report Number
    2520274-2014-14710
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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: THE PART RETURNED FOR INSPECTION. THE REPAIR TECHNICIAN REPORTED THE PART WAS WORN OUT. THE ITEM IS NOT REPAIRABLE; THE CAUSE OF THE ISSUE IS UNDETERMINED. PRODUCT DEVELOPMENT DETAILS, THE PART WAS RECEIVED WITH THE STOP SCREW, WHICH INSERTS INTO THE CANNULATED SCREW, NO LONGER CONNECTED TO THE DEVICE. PER THE ASSEMBLY GUIDE, THE SYNFRAME ACCESS AND RETRACTOR SYSTEM ALLOWS DIRECT VISUALIZATION AND STABLE RETRACTION FOR LESS INVASIVE SPINE SURGERY. THE CORE FUNCTION OF THE RING DEVICE IS TO PROVIDE A RIGID CONNECTION TO THE DESIRED RETRACTOR BLADES. UPON EXAMINATION, (ONE SYNFRAME HALF RING (PART# 387.337, LOT# 3072115, MFG DATE UNKNOWN) IT WAS SEEN THAT THE STOP SCREW WHICH INSERTS INTO THE CANNULATED SCREW IS NO LONGER CONNECTED TO THE DEVICE. IT IS LIKELY THAT THE DEVICE WAS DISASSEMBLED FOR STERILIZATION AND WAS NOT PROPERLY REASSEMBLED RESULTING IN THE LOSS OF THIS SCREW. ASSOCIATED DRAWINGS WERE REVIEWED. THE DRAWING CALLS OUT THE APPROPRIATE MATERIALS, DIMENSIONS, AND FINISHING PROCESSES FOR THE PROPER MANUFACTURING OF THIS INSTRUMENT. THE DESIGN WAS FOUND TO BE ADEQUATE FOR THE INTENDED USE OF THIS INSTRUMENT AND THE RISK ASSESSMENT ACCEPTABLY COVERS THIS COMPLAINT CONDITION. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: LOT 3072115: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN AND CANNOT BE TRACED. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT TWO SYNFRAME HALF RINGS WERE MISSING ONE OF TWO SCREWS USED TO CONNECT THE DEVICE TOGETHER. IT WAS DISCOVERED BEFORE A PROCEDURE; HOWEVER, THE SURGEON WAS STILL ABLE TO USE THE DEVICES IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734188 SYNFRAME HALF RING MISC ORTHO SURGICAL INSTR LXH SYNTHES USA 3072115

    Patients

    Seq Age Sex Outcome Treatment
    1