BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.3MM CANNULATED SCREW 32MM THREAD/140MM

    MDR report key: 12063566 · Received June 24, 2021

    Report

    Report Number
    2939274-2021-03213
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    UDI-DI
    10886982151339
    PMA / PMN Number
    K161616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, ON AN UNKNOWN PROCEDURE, THE (1) DEPTH GAUGE FOR SMALL SCREWS, (2) PROTECTION SLEEVE/ 11/8, (2) DRILL SLEEVE / 4.2MM, (2) SCREWDRIVER SHAFT SDDRIVE 165MM, (6) 2.8MM FIXED ANGLE DRILL GUIDE, (3) 7.3MM CANNULATED SCREW 32MM THREAD/140MM, (1) SCR RACK 6.5 TI&SS CANN SCRS-16/32 THRDS, (1) LCKNG ATTACH WASHER TRAY RFN-ADVANCED, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/RT-S, (2) 2.4 VA 2-CLMN VLR DRP 7H HD/3H SFT/LT-S HAVE AN UNKNOWN ALLEGATION. FIXED ANGLE GUIDES DON¿T FIT INTO VA LOCKING HOLES, SCREWS WERE STRIPPED IN PROCESS. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-TWO (22) DEVICES. THIS REPORT IS FOR (1) 7.3MM CANNULATED SCREW 32MM THREAD/140MM. THIS REPORT IS 11 OF 13 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952629 7.3MM CANNULATED SCREW 32MM THREAD/140MM SCREW,FIXATION,BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 209.940 10886982151339

    Patients

    Seq Age Sex Outcome Treatment
    1