BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER

    MDR report key: 8817593 · Received July 23, 2019

    Report

    Report Number
    2939274-2019-59319
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    June 28, 2019
    Report Date
    June 28, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034814216
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    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. A REVIEW OF THE DEVICE HISTORY RECORD DEVICE HISTORY LOT , PART #: 03.835.012S, SYNTHES LOT # H686786, LOT EXPIRATION: 30-JUN-2021, MANUFACTURING SITE: SYNTHES MONUMENT , RELEASE TO WAREHOUSE DATE: 23-JUL-2018. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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.. EXP.DATE PROVIDED FOR REPORTING. THE DEVICE WAS RECEIVED. 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

    PATIENT ID #: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ANTERIOR SPINAL FUSION, ONE (1) OUT OF THREE (3) SYNFIX EVOLUTION PROTECTION SLEEVE WAS LOST. TWO (2) SLEEVES WERE LOCATED ON THE BACK OF THE TABLE, THE THIRD WAS NOT LOCATED. THE SURGEONS VISUALLY INSPECTED THE WOUND AND COULD NOT LOCATE THE ITEM. A SEARCH WAS ALSO CONDUCTED IN THE OPERATING ROOM WITH NO FINDING OF THE ITEM.  A CT SCAN WAS PERFORMED POST-OPERATIVELY, THE SLEEVE WAS LOCATED AT THE ANTERIOR PROMINENCE OF S1. THERE WAS NO FURTHER SURGICAL ACTION IS BEING TAKEN AT THIS POINT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.  THIS REPORT IS FOR ONE (1) SYNFIX EVOLUTION PROTECTION SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613108 SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.835.012S H686786 10705034814216

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention