BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX TORQUE HANDLE

    MDR report key: 20176392 · Received September 9, 2024

    Report

    Report Number
    1526439-2024-02322
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 14, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034224367
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(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: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION SUMMARY 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. H4, H6: DEVICE HISTORY LOT A REVIEW OF THE RECEIVING INSPECTION (RI) FOR SFX TORQUE HANDLE, WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GB153831 WAS RELEASED IN ONE BATCH. ¿ BATCH1: LOT QTY OF 70 UNITS WERE RELEASED ON NOV 16, 2023 WITH NO DISCREPANCIES. SUPPLIER : DEPUY : 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. DEVICE HISTORY REVIEW RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AUG 14, 2024, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT ITEM WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. ALL INFORMATION REGARDING THIS EVENT HAS BEEN REPORTED. THIS REPORT IS FOR ONE (1) SFX TORQUE HANDLE FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295628 SFX TORQUE HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SPINE INC GB153831 10705034224367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown