BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPTICAL RATCHETING HANDLE

    MDR report key: 20237627 · Received September 17, 2024

    Report

    Report Number
    1526439-2024-02449
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034198743
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY REVIEW (DHR): A REVIEW OF THE RECEIVING INSPECTION ELLIPTICAL RATCHETING HANDLE WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GB60225 WAS RELEASED IN TWO BATCHES. SUPPLIER: GAUTHIER BIOMEDICAL, INC. BATCH 1: LOT QTY OF (B)(4) UNITS WAS RELEASED ON 02 SEP 2014 WITH NO DISCREPANCIES. BATCH 2: LOT QTY (B)(4) UNITS WERE RELEASED ON 27 AUG 2014 WITH NO DISCREPANCIES. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION IT WAS NOTICED THAT THE RATCHING MECHANISM WAS BROKEN, COULD NOT TURN TO REVERSE. THERE WERE NO BROKEN FRAGMENTS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901841 ELLIPTICAL RATCHETING HANDLE MISC ORTHO SURGICAL INSTR LXH DEPUY SPINE INC GB60225 10705034198743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown