BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAI COUNTER TORQUE

    MDR report key: 19123905 · Received April 17, 2024

    Report

    Report Number
    1526439-2024-01341
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 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. ADDITIONAL NARRATIVE: H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE SAI COUNTER TORQUE WAS OBSERVED CORROSION INSIDE THE INTERNAL SURFACE OF THE HOLE, 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. THEREFORE, THE REPORTED CONDITIONS CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST 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 CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS AND 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 DEPUY SYNTHES 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. THE DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. 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. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J EMPLOYEE. H3, H6: 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.

    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 REVIEW OF THE RECEIVING INSPECTION (RI) FOR SAI COUNTER TORQUE, WAS CONDUCTED IDENTIFYING THAT LOT NUMBER PC3238089 WAS RELEASED IN ONE BATCH. BATCH1: LOT QTY OF (B)(6) UNITS WERE RELEASED ON MAR 30, 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. PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT 279704055 SAI COUNTER TORQUE HAS WELDING WORN OUT BETWEEN HUB AND TUBE AND THE SURFACE BURRED . A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF UNABLE TO ASSEMBLE. FUNCTIONALITY ISSUES CAN NOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. 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 · 0

    IT WAS REPORTED THAT DURING A TRANSVERSE ILIAC ROD FIXATION (PELVIS) SURGERY ON (B)(6) 2024, DURING FINAL FASTENING OF THE SAI SCREW, ONLY ONE-THIRD OF THE TORQUE SHAFT WAS INSERTED INTO THE SAI COUNTER TORQUE IN QUESTION. FINAL FASTENING WAS DONE BY GRIPPING THE ROD WITH A ROD HOLDER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. UPON CHECKING THE INSTRUMENT AFTER SURGERY, IT WAS CONFIRMED THAT THE WELDS INSIDE THE TUBE HAD NOT BEEN GROUND AND THE SHAFT COULD NOT BE INSERTED. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232478 SAI COUNTER TORQUE CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA DEPUY SPINE INC PC3238089 10705034301242

    Patients

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