BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 8680441 · Received June 7, 2019

    Report

    Report Number
    8030965-2019-65077
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819968417
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.614.017, LOT: 5910493, MANUFACTURING SITE: SALZBURG, RELEASE TO WAREHOUSE DATE: 25. NOVEMBER 2011. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INVESTIGATION: THE RECEIVED DEVICE IS IN A USED AND WORN CONDITION. THE FRONT FACE FROM THE HOLDING THREAD FOR CANCELLOUS SYNAPSE SCREWS ON THE HOLDING SLEEVE IS WORN AND DEFORMED WHAT IS THE REASON FOR THE DEFICIENCY AS PER EVENT DESCRIPTION. INVESTIGATION CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT # 0000277191, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON (B)(6) 2019 DURING A CERVICAL FUSION PROCEDURE AT C1, C2 FOR A PATIENT WITH AN ATLAS FRACTURE, THE CANCELLOUS BONE SCREW SYNAPSE WAS STUCK AT THE HOLDING SLEEVE DURING INSERTION. SO, THE SURGEON CHANGED THE HOLDING SLEEVE TO AN ALTERNATIVE SLEEVE, HOWEVER, THE SURGEON FELT THE SAME FEELING AT THE SLEEVE. THE SURGEON ALSO USED ANOTHER UNKNOWN SCREW AND GOT STUCK AGAIN. THE PROCEDURE WAS COMPLETED AND THE SURGEON WAS ABLE TO INSERT FOUR (4) SCREWS INTO PROPER POSITION. THERE WAS A SURGICAL DELAY OF LESS THAN THIRTY (30) MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471894 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 5910493 07611819968417

    Patients

    Seq Age Sex Outcome Treatment
    1