BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS

    MDR report key: 9210749 · Received October 18, 2019

    Report

    Report Number
    8030965-2019-69201
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    September 20, 2019
    Report Date
    September 20, 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
    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. H3, H6: PART NUMBER: 03.614.017, SYNTHES LOT NUMBER: T130088, RELEASE TO WAREHOUSE DATE: 30-NOV-2015, MANUFACTURE SITE: TUTTLINGEN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE FIRST TWO (2) MILLIMETERS FROM THE THREADED TIP WERE FOUND STRIPPED/ DAMAGED. BESIDES THAT, THE RELEASE FUNCTION IS WORKING PROPERLY AND THE SURFACE HAS SOME WEAR AND TEAR SIGNS. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. SUMMARY THE COMPLAINT CONDITION IS CONFIRMED AS THE TIP'S THREAD IS STRIPPED/ DAMAGED. AFTER A VISUAL INSPECTION PER GUIDANCE 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. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 WAS 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 THERE WAS A POSTERIOR CERVICAL SPINAL FUSION PROCEDURE TREATING FRACTURE DUE TO DISH (DIFFUSE IDIOPATHIC SKELETAL HYPEROSTOSI). THE NURSE HAD DIFFICULTY CONNECTING THE HOLDING SLEEVE (03.614.017) TO A SCREW, FEELING RESISTANCE WHILE MAKING A FEW ATTEMPTS. THEY EXCHANGED OTHER COMPONENTS SUCH AS AN INNER SLEEVE AND ATTACHED THEM TO THE HOLDING SLEEVE, BUT IT WAS STILL DIFFICULT TO CONNECT TO THE SCREW. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT WITHOUT A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003307 THREADED HOLDING SLEEVE FOR POLYAXIAL SCREWS ORTHO, SURGICAL, MISC, INSTRUMENT LXH OBERDORF SYNTHES PRODUKTIONS GMBH T130088 07611819968417

    Patients

    Seq Age Sex Outcome Treatment
    1