BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT

    MDR report key: 16983253 · Received May 23, 2023

    Report

    Report Number
    3015781803-2023-00018
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SYNTHES TRAUMA : ORTHOSPIN
    Product Code
    KTT
    UDI-DI
    10886982338594
    PMA / PMN Number
    K202810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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. ADDITIONAL NARRATIVE: ADDITIONAL PRO-CODES: OSN 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. 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) 2023 THE MAX-FRAME STRUTS WERE NOT MOVING APPROPRIATELY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487661 MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES TRAUMA : ORTHOSPIN 1100012-01 10886982338594

    Patients

    Seq Age Sex Outcome Treatment
    1 Male MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT| MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-SHRT