BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X15 TORQUE DRIVER

    MDR report key: 17137395 · Received June 15, 2023

    Report

    Report Number
    1526439-2023-01090
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXX
    UDI-DI
    10705034221441
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J EMPLOYEE. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR X15 TORQUE DRIVER WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GB0907 WAS RELEASED IN ONE BATCH BATCH1: LOT UNITS WERE RELEASED ON (B)(6) 2007 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. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED, THAT THERE WERE NO COSMETIC DEFECTS WITHIN THE X15 TORQUE DRIVER. A DIMENSIONAL INSPECTION FOR THE X15 TORQUE DRIVER WAS NOT PERFORMED, AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED, USING TORQUE METER MOUNTZ EZ-TORQ III ID ADAPTOR VF1028000. DRAWING DWG REV. B MANUFACTURED WAS USED AS SOURCE OF SPECIFICATION. TORQUE SPECIFICATION FOR THE DEVICE WAS 2.75 - 3.25. ACTUAL MEASURED VALUES RANGE FROM 3.328-3.495. THE DEVICE WAS TESTING HIGH. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED, FOR THE X15 TORQUE DRIVER. THERE IS NO INDICATION, THAT A DESIGN OR MANUFACTURING ISSUE. THE OVER TORQUEING CONDITION CAN BE ATTRIBUTED TO MAINTENANCE OF THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED, THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED, THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: DWG REV. D / REV. B. DIMENSIONAL INSPECTION: N/A. 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, ON AN UNKNOWN DATE. THAT THE FOLLOWING DEVICES WAS RECEIVED AS BLIND UNIT, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB0907, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB131018, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB125164, PRODUCT CODE: 288306100, LOT#: GB114663. THIS REPORT IS FOR ONE (1) X15 TORQUE DRIVER. THIS IS REPORT 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778653 X15 TORQUE DRIVER SCREWDRIVER HXX DEPUY SPINE INC 288306100 GB0907 10705034221441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown