BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIA 2 BONE HARVESTING KIT 520MM STERILE

    MDR report key: 10635797 · Received October 6, 2020

    Report

    Report Number
    8030965-2020-07740
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRX
    UDI-DI
    07612334142351
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, H4, H6- COMPLAINT IS CONFIRMED AS WE ARE ABLE TO CONFIRM COMPLAINT DESCRIPTION (BROKEN) BASED ON THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED THEREFORE NO FURTHER INVESTIGATION POSSIBLE. 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 (INFORMATION OR/AND MATERIAL), THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT PART NUMBER:03.404.000S, SYNTHES LOT NUMBER: 55P2147, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 30APR2020, EXPIRATION DATE: 01MAY2021, SUPPLIER: (B)(4). NR# 0003925 WAS GENERATED DURING PRODUCTION FOR DAMAGED TAMPER EVIDENT LABELS ON PACKAGING. PACKING WAS RE-WORKED AND PARTS RELEASED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE IT IS NOT RELATED TO COMPLAINT CONDITION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, 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

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. (B)(4). 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) 2020, A DEBRIDEMENT PROCEDURE FOR A SUSPECTED INFECTED TISSUE WITHIN THE LEFT FEMUR WAS PERFORMED. THE SURGEON COMPLETED THE IRRIGATION AND THEN PLACED THE RIA II OVER THE REAMING ROD THROUGH THE CANAL. THE SURGEON INSERTED A 2.5MM REAMING ROD DOWN THE INTRAMEDULLARY CANAL OF THE FEMUR USING THE ENTRY POINT OF THE NAIL THAT WAS TAKEN OUT. IT WAS THEN DISCOVERED THAT THERE WAS A DEFORMATION OF THE SEAL WITHIN THE TUBE ASSEMBLY. THE SURGEON INSPECTED THE RIA TO SEE IF THE SEAL COULD BE REPLACED. THE TUBE ASSEMBLY WAS DAMAGED, SO THE SURGEON DECIDED TO USE ANOTHER PRODUCT (CANAL BRUSH) TO COMPLETE THE PROCEDURE. THE PROCEDURE HAD A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: : 2.5MM SYNREAM REAMING ROD (PART # 352.032S, LOT # 6L09268, QUANTITY UNKNOWN), REAMER HEAD FOR RIA 2 (PART # 03.404.016S LOT # 38P2161, QUANTITY UNKNOWN), UNKNOWN STRYKER POWER TOOL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103460 RIA 2 BONE HARVESTING KIT 520MM STERILE ARTHROSCOPE HRX OBERDORF SYNTHES PRODUKTIONS GMBH 55P2147 07612334142351

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention REAMER HEAD F/RIA 2 Ø10| SYNREAM REAMING ROD Ø2.5 SHORT L950| UNK - RIA| UNK - STRYKER POWER TOOL