BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA

    MDR report key: 14219619 · Received April 27, 2022

    Report

    Report Number
    8030965-2022-02738
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 27, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819425231
    PMA / PMN Number
    K100776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. ADDITIONAL CODE - HRS. ADDITIONAL 510K - K103243. 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 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022 DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY WITH THE PLATE AND THE LOCKING SCREW NO TORQUE WAS APPLIED WHEN TRYING TO INSERT THE LOCKING SCREW INTO THE MOST DISTAL HOLE OF THE PLATE. SINCE THE ANGLE OF THE LOCKING SCREW WAS NOT LARGE, IT WAS CONSIDERED THAT THE LOCK FAILURE WAS CAUSED BY THE LOCKING SCREW, BUT IT DID NOT LOCK EVEN WITH ANOTHER LOCKING SCREW. THE THREAD MECHANISM OF THE PLATE HOLE MIGHT HAVE BEEN BROKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636417 VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE HWC SYNTHES GMBH 8L90567 07611819425231

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VA-LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT