BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT FOR RIA 2 520MM

    MDR report key: 10370066 · Received August 5, 2020

    Report

    Report Number
    2939274-2020-03407
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 15, 2020
    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
    OK, 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE DRIVE SHAFT FOR RIA 2 520MM (P/N: 03.404.035, LOT NUMBER: H870246) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE AUGUR TIP HAD BROKEN OFF. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE AUGUR TIP HAD BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 # H870246, SUPPLIER LOT # H870246, RELEASE TO WAREHOUSE DATE: 27 NOV 2019; 12 DEC 2019; 23 JAN 2020, 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 · 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: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    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

    IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT PRESENTED WITH A NONUNION OF THE MIDSHAFT HUMERUS. DRIVE SHAFT FOR RIA 2 WAS UTILIZED TO OBTAIN A BONE GRAFT FROM THE PATIENT'S LEFT FEMUR. THE APPROACH WAS MADE AND AN ENTRY POINT AT THE TIP OF THE GREATER TROCHANTER WAS MADE USING GUIDE PIN AND THE TAPERED DRILL BIT. A REAMER HEAD WAS SELECTED AND SHAFT BROKE AT THE LEVEL OF THE LESSER TROCHANTER. FLEXIBLE REAMERS WERE REUSED UP TO 12 MM TO JUST BELOW THE LESSER. A SECOND DRIVE SHAFT FOR RIA 2 PASSED AND BROKE AT THE SAME LEVEL OF THE FEMUR AND AT THE SAME SPOT OF THE SHAFT JUST BELOW THE IMPELLER PORTION. THE RIA WAS USED WITH A 12.5 MM REAMER HEAD, THE BONE GRAFT WAS OBTAINED UNEVENTFULLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS WAS SUCCESSFUL. CONCOMITANT DEVICES: REAMER HEAD (PART# 03.404.021S, LOT# UNKNOWN, QUANTITY# 1); GUIDE WIRE (PART# 357.399, LOT# UNKNOWN, QUANTITY# 1); REAMING ROD (PART# 351.706S, LOT# UNKNOWN, QUANTITY# 1); REAMER (PART# 357.403, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) DRIVE SHAFT FOR RIA 2 520MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833829 DRIVE SHAFT FOR RIA 2 520MM ARTHROSCOPE HRX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.035 H870246 10886982274243

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 12.5MM REAMER HEAD FOR RIA 2 STERILE| 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE| 3.2MM GUIDE WIRE 400MM| 6.0MM/10.0MM STEPPED DRILL BIT CANNU/LRG QC/435MM