BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIBUNION PL, 3.5 MM OFFSET, SHORT STER

    MDR report key: 16132586 · Received January 10, 2023

    Report

    Report Number
    3020584246-2023-00001
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    December 15, 2022
    Manufacturer
    SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    HRS
    UDI-DI
    00815432027149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REVISED A MINIBUNION CASE. ON (B)(6) 2022 IT WAS DISCOVERED THAT THE OBLIQUE SCREW WAS BACKING OUT. THE IMPLANT WAS REMOVED AND A MINI-FRAG T-PLATE WAS USED TO FIXATE THE CORRECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MINIBUNION PLATE, 3.5MM OFFSET, SHORT ¿ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645417 MINIBUNION PL, 3.5 MM OFFSET, SHORT STER PLATE, FIXATION, BONE HRS SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC MiniBunion Plate, 3.5mm Offset, Short - Sterile 00815432027149

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - SCREWS: TRAUMA