BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 DIA DB 6 STOP 13 LNTH 90 SCRDRIVER

    MDR report key: 11962763 · Received June 8, 2021

    Report

    Report Number
    2939274-2021-02843
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013497
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRO-CODE: DZJ. WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A DRILL BIT AND 2.0MM TITANIUM MATRIX MANDIBLE SCREW THAT WAS BROKEN. A BROKEN DRILL BIT WAS A 1.5 DRILL BIT FOR THE 90-DEGREE SCREWDRIVER SELF-TAPPING MANDIBLE AND THE SCREW WITH 2.0 SCREW 8MM LENGTH AND THE DRILL BIT WAS A DRILL BIT AND THE SCREWDRIVER BROKE FOR THIS ADVERSE EVENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.   THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851828 1.5 DIA DB 6 STOP 13 LNTH 90 SCRDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.041 10887587013497

    Patients

    Seq Age Sex Outcome Treatment
    1