BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 12432189 · Received September 7, 2021

    Report

    Report Number
    8030965-2021-07526
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Report Date
    August 9, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819775459
    PMA / PMN Number
    K192646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: KWQ AND NKG. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE THE STAR DRIVE SHAFT WAS DEFORMED. THERE WAS NO AFFECT ON THE SURGERY. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332256 STARDRIVE SCREWDRIVER SHAFT T8 105MM SCREWDRIVER HXX SYNTHES GMBH 07611819775459

    Patients

    Seq Age Sex Outcome Treatment
    1