BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12191767 · Received July 19, 2021

    Report

    Report Number
    8030965-2021-05890
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Report Date
    June 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    UDI-DI
    07611819690691
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HXP. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE TIP OF THE PARTS WAS BENT. IT WAS UNKNOWN HOW THIS DAMAGE HAPPENED. THERE WAS NO PROCEDURE AND PATIENT INVOLVED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088598 DEPTH GAUGE FOR 1.3MM/1.5MM AND 2.0MM SCREWS GAUGE,DEPTH HTJ SYNTHES GMBH 07611819690691

    Patients

    Seq Age Sex Outcome Treatment
    1