BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER PRIME TORQUE HANDLE

    MDR report key: 20159200 · Received September 6, 2024

    Report

    Report Number
    1526439-2024-02287
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 13, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034507750
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. H11: ADDITIONAL NARRATIVE: H3, H4, H6: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VIPER PRIME TORQUE HANDLE WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GB152787 RELEASED IN ONE BATCH RELEASED NOVEMBER 02, 2023 WITH NO DISCREPANCIES. SUPPLIER: GAUTHIER BIOMEDICAL, INC. 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. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 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 ON AUGUST 13, 2024 DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT THE SITE, IT WAS OBSERVED THAT THE TORQUE HANDLE HAD BEEN FOUND TO BE OUT OF SPECIFICATION; THE TORQUE HAD TESTED HIGH. THERE HAD BEEN NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864872 VIPER PRIME TORQUE HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC GB152787 10705034507750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown