BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE SHAFT FOR RIA 2 520MM

    MDR report key: 10968972 · Received December 8, 2020

    Report

    Report Number
    8030965-2020-09503
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 13, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    UDI-DI
    07612334143037
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DRIVER SHAFT F/RIA 2 L520 (P/N: 03.404.035, LOT #: H860686) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, SLIGHT DEFORMATION WAS OBSERVED ON THE TIP. THE EMBEDDED DEVICE CANNOT BE CONFIRMED AS NO X-RAYS WERE PROVIDED. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE OUTER DIAMETER OF THE AUGER WAS MEASURED AND IS WITHIN THE SPECIFICATION PER RELEVANT DRAWING. THE OUTER DIAMETER OF THE NITINOL SHAFT WAS MEASURED AND IS WITHIN THE SPECIFICATION PER RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE DRIVER SHAFT F/RIA 2 L520 (P/N: 03.404.035, LOT #: H860686) AS THE TIP WAS DEFORMED NOT BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE FOR DEFORMATION IS LIKELY DUE TO USE OF THE DEVICE. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 03.404.035, SYNTHES LOT # H860686, SUPPLIER LOT # H860686, RELEASE TO WAREHOUSE DATE: 05 NOV 2019, SUPPLIER: (B)(4). NO NCR'S WERE 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. 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

    ADDITIONAL DEVICE PRODUCT CODE: HRX. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 )( AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2020, THE REAMER / IRRIGATOR / ASPIRATOR (RIA) 2 SINGLE-USE SET WITH CANCELLOUS BONE CONTAINER WAS USED. DURING INSERTION OF THE 1ST DRIVE SHAFT WITH REAMING HEAD SIZE 10, THE REAMING HEAD CAME LOOSE UNNOTICED DURING REAMING AND THEN THE TIP OF THE DRIVE SHAFT BROKE OFF AND REMAINED IN THE FEMUR. THERE WAS SURGICAL DELAY OF 180 MINUTES DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SWITCH TO RIA I. PATIENT OUTCOME IS REPORTED AS GOOD. CONCOMITANT DEVICE REPORTED: 10.0MM REAMER HEAD FOR RIA 2 STERILE (PART # 03.404.016S, LOT # 26P2098, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVE SHAFT FOR RIA 2 520MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430504 DRIVE SHAFT FOR RIA 2 520MM REAMER HTO SYNTHES GMBH H860686 07612334143037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 10.0MM REAMER HEAD FOR RIA 2 STERILE| 10.0MM REAMER HEAD FOR RIA 2 STERILE