BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90 SCREWDRIVER

    MDR report key: 9922100 · Received April 3, 2020

    Report

    Report Number
    2939274-2020-01702
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    March 9, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013305
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: DZJ, HXX. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. 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 PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 DURING A RIB FIXATION PROCEDURE, THE 90-DEGREE SCREWDRIVER WOULD NOT WORK WHEN INSERTING AN UNKNOWN SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE SURGEON USED A DIFFERENT UNKNOWN SCREWDRIVERS. THERE WAS A SURGICAL DELAY FIVE (5) MINUTES AND THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN).. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387007 HANDLE FOR 90 SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.004 10887587013305

    Patients

    Seq Age Sex Outcome Treatment
    1