BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 13285417 · Received January 18, 2022

    Report

    Report Number
    8030965-2022-00380
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    January 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819187481
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.505.004. LOT: 8140696. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 14.MAY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO CONNECT FIRMLY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HANDLE FOR 90° SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917668 HANDLE FOR 90° SCREWDRIVER SCREWDRIVERS HXX SYNTHES GMBH 8140696 07611819187481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SHAFT