BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5

    MDR report key: 20169697 · Received September 9, 2024

    Report

    Report Number
    1526439-2024-02306
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 16, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    GEA
    UDI-DI
    10705034301242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE SAI COUNTER TORQUE WAS OBSERVED WEAR ON THE SURFACE DUE TO NORMAL USE. ADDITIONALLY, PART OF WHAT APPEARS TO BE THE WELD THAT JOINS THE BASE OF THE ASSEMBLY WITH THE TUBE IS PROTRUDING. THIS CONDITION CAN MAKE IT DIFFICULT TO SLIDE CORRECTLY WITH THE MATING DEVICE. HOWEVER, THE CONDITION OF FELL APART CANNOT BE CONFIRMED DUE TO THE DEVICE DOES NOT COME APART. THEREFORE, THE REPORTED CONDITION CAN BE PARTIALLY CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. A DIMENSIONAL INSPECTION WAS PERFORMED AND MET SPECIFICATIONS. A FUNCTIONAL EVALUATION WAS UNABLE TO BE PERFORMED DUE TO THE MATING DEVICE WAS NOT RETURNED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SAI COUNTER TORQUE WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): A REVIEW OF THE RECEIVING INSPECTION (RI) SAI COUNTER TORQUE , WAS CONDUCTED IDENTIFYING THAT LOT NUMBER WAS PC3238089 RELEASED IN ONE BATCH. BATCH 1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 30 MAR 2016 WITH NO DISCREPANCIES. SUPPLIER; (B)(4). AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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

    IT WAS REPORTED THAT DURING A POSTERIOR LUMBAR FUSION FOR DEGENERATIVE DISEASE ON (B)(6) 2024, DURING THE FINAL FASTENING OF THE SAI SCREW, IT WAS NOT POSSIBLE TO INSERT THE TORQUE DRIVER INTO THE SAI COUNTER TORQUE IN QUESTION. THE WELDED PART OF THE SAI COUNTER TORQUE IN QUESTION WAS PROTRUDING, SO THE SCREWDRIVER COULD NOT BE INSERTED. SINCE THE FINAL FASTENING WAS DONE BY GRIPPING THE ROD WITH A ROD HOLDER AND APPLYING TORQUE, THERE WERE NO PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536615 VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5 CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA DEPUY SPINE INC PC3238089 10705034301242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN SCREWDRIVERS| UNKNOWN SCREWS