BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.8MM THREADED DRILL GUIDE

    MDR report key: 12543914 · Received September 28, 2021

    Report

    Report Number
    8030965-2021-08107
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Report Date
    August 31, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    07611819245907
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 323.027, LOT: 2232982, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 09 JANUARY 2007, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 2.8MM THREADED DRILL GUIDE IS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439916 2.8MM THREADED DRILL GUIDE GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 2232982 07611819245907

    Patients

    Seq Age Sex Outcome Treatment
    1