BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 16195904 · Received January 18, 2023

    Report

    Report Number
    8030965-2023-00616
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    September 22, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRX
    UDI-DI
    07611819739208
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    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. ADDITIONAL NARRATIVE: PROCODE: ADDITIONAL DEVICE PRODUCT CODES: HTO. INITIAL REPORTER OCCUPATION: REPORTER IS A J&J EMPLOYEE. PART# 314.743, SYNTHES LOT#: H890677, SUPPLIER LOT#: H890677, RELEASE TO WREHOUSE DATE: 23 JUL 2020, SUPPLIER: CRITERION TOOL & DIE, INC. NO NCR'S GENERATED DURING PRODUCTION. 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. 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 THE TIP OF RIA DRIVESHAFT L520, P/N: 314.743, WAS BROKEN. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EVALUATION. NO OTHER PROBLEMS IDENTIFIED. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO NOT BEING APPLICABLE TO THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE RIA DRIVESHAFT L520, P/N: 314.743 WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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. DRAWING/SPECIFICATIONS REVIEWED? YES, REVIEWED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE END OF THE L360 DRIVE SHAFT AND THE LEGS OF THE 12 MM RIA MILLING CUTTER SPLIT. PARTICLES REMAINED IN THE CHANNEL. THERE WAS A 30-MINUTE DELAY IN RELATION TO THE REPORTED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT STATUS/OUTCOME WAS REPORTED AS OK. A FRAGMENT REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822025 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA ARTHROSCOPE HRX SYNTHES GMBH H890677 07611819739208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 12.0MM REAMER HEAD FOR REAMER/IRRIGATOR/ASPIRATOR| RIA TUBEASSEMBLY MIN-L 360 F/314.742