BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA

    MDR report key: 12665191 · Received October 20, 2021

    Report

    Report Number
    8030965-2021-08812
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 22, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRX
    UDI-DI
    07611819739192
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    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: UPDATED DATA: D7A. INVESTIGATION SUMMARY VISUAL INSPECTION: THE RIA DRIVESHAFT L360 (PART# 314.742 LOT# H780185 QTY# 1) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT IS OBSERVED THAT THE DISTAL TIP OF THE DRIVESHAFT WAS BROKEN. THE BROKEN TIP FRAGMENT WAS NOT RETURNED. NO OTHER ISSUES WERE FOUND WITH THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS (CURRENT AND MANUFACTURED TO) WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THE COMPLAINT IS BEING CONFIRMED FOR THE RIA DRIVESHAFT L360 (PART# 314.742 LOT# H780185 QTY# 1). A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED ISSUE FROM THE AVAILABLE INFORMATION. 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 UPON THESE RESULTS, 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. CORRECTED DATA: D9, H3, H6.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY. CUSTOMER QUALITY INVESTIGATION: THE DEVICE WAS NOT RETURNED. A PHOTO-INVESTIGATION WAS PERFORMED ON THE IMAGE RECEIVED. UPON INSPECTING THE IMAGE PROVIDED, THE COMPLAINT CONDITION WAS CONFIRMED AS THE DISTAL TIP OF THE COMPLAINT DEVICE HAD BROKEN OFF. HOWEVER, A DEFINITIVE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE IMAGE. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/ SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART # 314.742, SYNTHES LOT # H780185, SUPPLIER LOT # H780185, RELEASE TO WAREHOUSE DATE: 26 JUN 2019, SUPPLIER: CRITERION TOOL & DIE, 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE RIA TRANSMISSION SHAFT WAS SPLIT. ALL FRAGMENTS ARE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565326 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA ACCESSORIES, ARTHROSCOPIC HRX SYNTHES GMBH H780185 07611819739192

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male