BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT FOR RIA 2 520MM

    MDR report key: 12069529 · Received June 25, 2021

    Report

    Report Number
    2939274-2021-03243
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRX
    UDI-DI
    10886982274243
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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: D7A; H4. 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 · 1

    PRODUCT COMPLAINT # (B)(4). PROCODE: ADDITIONAL PRODUCT CODE: HTO. INVESTIGATION SUMMARY: INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE DRIVE SHAFT FOR RIA 2 520 MM (P/N: 03.404.035, LOT #: H870246) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. THE DEVICE FAILURE/DEFECT WAS IDENTIFIED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT WAS NOT CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE DRIVE SHAFT FOR RIA 2 520 MM (P/N: 03.404.035, LOT #: H870246). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 HISTORY: LOT PART # 03.404.035, SYNTHES LOT # H870246, SUPPLIER LOT # H870246, RELEASE TO WAREHOUSE DATE: NOV 27, 2019; DEC 12, 2019; JAN 23, 2020. SUPPLIER: (B)(4) INC. NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. WHILE REAMING THE FEMUR WITH A 10.5MM REAMER IRRIGATOR ASPIRATOR (RIA) 2 HEAD, THE HEAD BROKE OFF AND LEFT THE FOUR TABS IN THE FEMUR. THEN OPENED AN 11.5 HEAD, AND IT BROKE THE SECOND OR THIRD IN AND OUT MOTION. THE SURGEON THEN PASSED REGULAR REAMER TO SIZE 11MM AND COMPLETED THE CASE WITH AN ADDITIONAL 11.5MM RIA 2 HEAD. CASE DELAYED BY 40 MINUTES. THE SURGEON RETRIEVED THE 8 METAL TABS THAT WERE LEFT FROM BROKEN HEADS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 40 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) DRIVE SHAFT FOR RIA 2. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966529 DRIVE SHAFT FOR RIA 2 520MM ACCESSORIES, ARTHROSCOPIC HRX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.035 H870246 10886982274243

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR 10.5MM REAMER HEAD FOR RIA 2 STERILE| 11.5MM REAMER HEAD FOR RIA 2 STERILE