BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM

    MDR report key: 19041662 · Received April 4, 2024

    Report

    Report Number
    1526439-2024-01198
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    January 5, 2024
    Manufacturer
    DEPUY SPINE INC
    Product Code
    GEA
    UDI-DI
    10705034199009
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: INITIAL REPORTER IS A SYNTHES EMPLOYEE. A REVIEW OF THE RECEIVING INSPECTION (RI) FOR APPROXIMATOR FC SLEEVE WAS CONDUCTED IDENTIFYING THAT LOT NUMBER NW276580 WAS RELEASED IN ONE BATCH. SUPPLIER: NORWOOD MEDICAL ¿ BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 18 NOV 2021 WITH NO DISCREPANCIES. 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 DEVICE FOUND THAT THE APPROXIMATOR FC SLEEVE HAS RETAINING PIN BENT INWARDS IN THE MIDDLE OF THE SHAFT. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE APPROXIMATOR FC SLEEVE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A PHOTO WAS RETURNED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT APPROXIMATOR FC SLEEVE HAD A RETAINING PIN BENT INWARDS IN THE MIDDLE OF THE SHAFT. THE DEVICE EXHIBITS DAMAGE CONSISTENT WITH REPEATED USE. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. 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

    DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE VIPER SC SCREWDRIVER AND EXPEDIUM DRIVERS ARE DEFECTIVE AND CANNOT BE USED. IT HAS NO GRIP ON THE TIP AND HAS ROUNDED TIP. THE PATIENT WAS INVOLVED, BUT DUE TO AVAILABILITY OF SPARE DEVICES ON THE TRAY THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR AN EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339246 EXPEDIUM SPINE SYSTEM CLIP-ON RED.DRIVER W/DOVETAIL 5.5MM CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA DEPUY SPINE INC NW276580 10705034199009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EXPEDIUM 5.5 DI FA INSTRUMENTS| EXPEDIUM NM ALPHA SET CASE/TRA