BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE SHAFT FOR RIA 2 520MM

    MDR report key: 12482768 · Received September 16, 2021

    Report

    Report Number
    2939274-2021-05470
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982274243
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4: LOT D9 H3, H4, H6: PART # 03.404.035 SYNTHES LOT # J001373 SUPPLIER LOT # J001373 RELEASE TO WAREHOUSE DATE: MAY 4, 2021 SUPPLIER: MARK TWO ENGINEERING INC. 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. VISUAL INSPECTION: THE DRIVE SHAFT FOR RIA 2 520MM (PN: 03.404.035, LN: J001373) WAS RETURNED TO CUSTOMER QUALITY (CQ) WEST CHESTER FOR INVESTIGATION. AN X-RAY IMAGE WAS PROVIDED. VISUAL INSPECTION OF THE RETURNED DEVICE AND PROVIDED X-RAY IMAGE FOUND NO ISSUES WITH THE DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE DRIVE SHAFT WAS NOT RETURNED WITH A MATING DEVICE TO EVALUATE THE COMPLAINT CONDITION. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO, UNABLE TO PERFORM FUNCTIONAL TEST TO EVALUATE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DRAWING : MANUFACTURED REVISION SPEC: DIAMETER OF THE DRIVE SHAFT MEASURED: DIAMETER OF THE DRIVE SHAFT: CONFORMING CALIPER; RESULT: PASS DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE DRAWINGS RELEASED DURING THE MANUFACTURING PERIOD AND CURRENT PERIOD WAS REVIEWED: CURRENT AND MANUFACTURED REVISIONS NITINOL SHAFT COMPLAINT CONFIRMED: THE COMPLAINT CONDITION CANNOT BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED FOR THE DRIVE SHAFT FOR RIA 2 520MM (PN: 03.404.035, LN: J001373). A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE 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. 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 PRODUCT CODE: HRX.. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. 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, WHILE REAMING FOR A PIRIFORMIS NAIL USING THE RIA 2 THE MALUNION, INITIALLY REAMED WITH AN 8.5 WITH THE FLEXIBLE REAMERS. THE RIA FAILED BEFORE REACHING THE LEVEL OF THE LESSER TROCHANTER, FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - NAILS: (PART# UNKNOWN; LOT# UNKNOWN; 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
    1381691 DRIVE SHAFT FOR RIA 2 520MM REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.035 J001373 10886982274243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAILS| UNK - REAMERS: REAMER HEAD| UNK - REAMING RODS| UNK - NAILS| UNK - REAMERS: REAMER HEAD| UNK - REAMING RODS