BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNFRAME RING CLAMP

    MDR report key: 9324476 · Received November 14, 2019

    Report

    Report Number
    2939274-2019-62211
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 1, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034771137
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (P/N: 387.347, LOT #: 1488779) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WERE SCRATCHES ON THE DEVICE BUT THAT HAS NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. FUNCTIONAL TEST: THE SYNFRAME CLAMP WAS RETURNED BY ITSELF. PER SYNFRAME RL AND SYNFRAME MODULAR APPROACH AND RETRACTION SYSTEM TECHNIQUE GUIDE (DSEM/SPN/0616/0530 09/16), THE RIB RETRACTOR WAS MOUNTED TO THE SMALLER OPENING OF THE CLAMP. RIB RETRACTOR DRAWING WERE REVIEWED, THE MINIMUM SPECIFICATION OF THE RIB RETRACTOR WAS DETERMINED TO BE 5.70 MM. THE FUNCTIONAL TEST WAS PERFORMED WITH THE 5.70 MM GAUGE PIN (GP29) AVAILABLE AT CQ. THE 5.70 MM GAUGE PIN WAS SNAPPED INTO THE SMALLER OPENING OF THE CLAMP. ONCE THE GAUGE PIN WAS MOUNTED ON TO THE CLAMP, IT WAS TIGHTENED AND AFFIXED APPROPRIATELY. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? NO. COMPLAINT CONFIRMED? NO, THE 5.70 MM GAUGE PIN WAS MOUNTED ON THE RETURNED DEVICE WITH NO DEFECTS FOUND. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE SYNFRAME CLAMP F/HOLDINGRING NO. 387.336 (P/N: 387.347, LOT #: 1488779). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART:387.347, LOT:1488779, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JUNE 16, 2006. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    ALIF DISC REPLACEMENT WAS THE SURGICAL PROCEDURE THAT WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS COMPANY SALES CONSULTANT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, FOUR (4) SYNFRAME RING CLAMPS IDENTIFIED AS NOT HOLDING RETRACTOR FOR SYNFRAME SYSTEM. PROCEDURE WAS DELAYED FOR FIVE (5) MINUTES. DIFFERENT RING CLAMPS WERE USED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SYNFRAME RETAINING RING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SYNFRAME RING CLAMP. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114784 SYNFRAME RING CLAMP MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 387.347 10705034771137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SYNFRAME RETAINING RING