BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS

    MDR report key: 12318906 · Received August 13, 2021

    Report

    Report Number
    8030965-2021-06643
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    July 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXP
    UDI-DI
    07611819690691
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODE: HTJ. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. 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 HISTORY LOT: PART # 03, LOT # L561764, RELEASE TO WAREHOUSE DATE: 02 OCT 2017 , MANUFACTURER: (B)(4), SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 ON AN UNKNOWN DATE DURING A HAND FRACTURE PROCEDURE, THE VA HAND INSTRUMENT SET WAS OPENED AND THE DEPTH GAUGE WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DEPTH GAUGE FROM A NEW KIT OF INSTRUMENTS. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217095 DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS INSTR,BENDING OR CONTOURING HXP SYNTHES GMBH L561764 07611819690691

    Patients

    Seq Age Sex Outcome Treatment
    1