BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIA 2 BONE HARVESTING KIT 520MM STERILE

    MDR report key: 12521504 · Received September 23, 2021

    Report

    Report Number
    8030965-2021-07957
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    August 25, 2021
    Report Date
    August 26, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRODUCT CODE: HRX. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE 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 LOT: PART #: 03.404.000S. LOT #: 88P5865. MANUFACTURING SITE: (B)(4). SUPPLIER: SYNTHES USA HQ, INC. RELEASE TO WAREHOUSE DATE: FEB 5, 2021. EXPIRATION DATE: FEB 01, 2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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) 2021, THE PATIENT UNDERWENT FOR A SURGERY. WHILE USING THE RIA 2 WITH REAMER HEAD, WHILE THEY REMOVED THE DRIVER SHAFT AND SILICONE TUBING, THE SILICONE TUBING WAS TORN. THE SURGERY DID NOT GO THROUGH WELL AND THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - REAMERS: REAMER HEAD: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) RIA 2 BONE HARVESTING KIT 520MM STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415101 RIA 2 BONE HARVESTING KIT 520MM STERILE REAMER HTO SYNTHES GMBH 88P5865

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention UNK - REAMERS: REAMER HEAD