BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX X20 TORQUE DRIVER SHAFT

    MDR report key: 12847425 · Received November 19, 2021

    Report

    Report Number
    1526439-2021-02441
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 26, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034224428
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PART # 289410300, LOT # 0309NT, SUPPLIER: NORWOOD MEDICAL. BATCH # 1 (B)(4) RELEASE TO WAREHOUSE DATE: APRIL 13, 2009. BATCH # 2 (B)(4) RELEASE TO WAREHOUSE DATE: APRIL 15, 2009. NO NCR'S WERE GENERATED DURING PRODUCTION. VISUAL INSPECTION: THE COMPLAINT DEVICE SFX X20 TORQUE DRIVER SHAFT (PRODUCT CODE: 289410300, LOT NUMBER: 0309NT) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. THE TIP OF THE DRIVER SHAFT WAS BROKEN. THE DEVICE HAD CIRCULAR MARKS ON THE SHAFT WHICH IS CONSISTENT WITH REGULAR USE OF THE DEVICE. THE PHOTOGRAPHS OF THE DEVICE WERE RECEIVED FOR INVESTIGATION AND THE FINDINGS WERE CONSISTENT WITH PHYSICAL DEVICE INVESTIGATION. DEVICE/DEFECT IDENTIFIED: YES. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF THE DRAWINGS WERE REVIEWED. SFX X20 TORQUE DRIVER SHAFT. DIMENSIONAL INSPECTION: THIS IS A POST MANUFACTURING DAMAGE, AND ACCORDING TO FRANCHISE PROCEDURE A DIMENSIONAL INSPECTION IS NOT NEEDED. COMPLAINT CONFIRMED: COMPLAINT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION DURING PHYSICAL INVESTIGATION. CONCLUSION: THE COMPLAINT ON THE QUICK CONNECT POLY DRIVER WAS CONFIRMED DURING INVESTIGATION. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED DURING INVESTIGATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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. 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

    REPORTER IS A J&J SALES REPRESENTATIVE. THE SUBJECT DEVICE HAS BEEN 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 ON AN UNKNOWN DATE, DURING POSTERIOR SPINAL FUSION SURGERY THE SFX FINAL TIGHTENER TIP BROKE OFF INTO THE CROSSLINK. FRAGMENTS WERE GENERATED AND REMOVED. IT TOOK A WHILE TO GET THE TIP OUT. THEY USED OTHER TOOLS TO REMOVE THE TIP. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) SFX X20 TORQUE DRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743310 SFX X20 TORQUE DRIVER SHAFT DRIVER, PROSTHESIS HWR DEPUY SPINE INC 289410300 0309NT 10705034224428

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - CONNECTOR.