BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIA 2 BONE HARVESTING KIT 520MM STERILE

    MDR report key: 10637274 · Received October 6, 2020

    Report

    Report Number
    2939274-2020-04534
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 15, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRX
    UDI-DI
    10886982274236
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER TELEPHONE NUMBER: (B)(6). INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY: PART # 03.404.000S. SYNTHES LOT # 65P4339. SUPPLIER LOT # 65P4339. RELEASE TO WAREHOUSE DATE: 18 AUG 2020. EXPIRATION DATE: 31 JUL 2021. MANUFACTURED BY JABIL (B)(4). JBL-NR-0003925 WAS GENERATED FOR A DEVIATED KIT/LABEL PROCESS OUTLINED IN THE RIA 2 KIT BOM AND PACKAGING MODIFICATION MEMO JBL-NR-0003925_65P4332. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE USE AS-IS WAS APPROVED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT 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

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION SURGERY FOR A REMOVAL OF A FAILED COMPETITOR'S CONSTRUCT AND NON-UNION. A RIA 2 BONE HARVESTING KIT WAS DONE TO GRAFT THE SAME FEMUR. DURING THE RIA, THE RIA TUBE ASSEMBLY CLOGGED UP TWICE WHICH STOPPED THE FLOW OF IRRIGATION AND ASPIRATION. IT IS UNKNOWN EXACTLY WHY THE ASSEMBLY CLOGGED UP BUT A STRINGY ENDOSTEAL TISSUE POTENTIALLY FROM THE NON UNION SITE WAS TAKEN OUT OF THE TUBE ASSEMBLY. ONLY A SMALL AMOUNT OF BONE GRAFT WAS COLLECTED AND THE SURGERY PROCEEDED. THE SURGEON ENDED UP DOING AN ILLIAC CREST BONE GRAFT TO SUPPLEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100463 RIA 2 BONE HARVESTING KIT 520MM STERILE ACCESSORIES, ARTHROSCOPIC HRX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.000S 65P4339 10886982274236

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention