BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L22 TAN

    MDR report key: 17372180 · Received July 21, 2023

    Report

    Report Number
    8030965-2023-09100
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    May 26, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819980686
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H4, H6 THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE VA LOCKSCR Ø2.4 SELF-TAP L22 TAN WAS FOUND BROKEN IN TWO PARTS. THE BROKEN FRAGMENT WAS RETURNED AND THE REPORTED CONDITION CAN BE CONFIRMED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE VA LOCKSCR Ø2.4 SELF-TAP L22 TAN WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: THE DRAWING NUMBER CANNOT BE CONFIRMED BECAUSE THE DHR REVIEW COULD NOT BE COMPLETED AND ONLY THE CURRENT VERSION IS AVAILABLE. / 2.4MM VARIABLE ANGLE LOCKING SCREW, SELF-TAPPING, STARDRIVE RECESS, _SUSA, REV. H CURRENT. DIMENSIONAL INSPECTION: N/A. 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 AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE DISTAL RADIUS LOCKING SCREWS WERE BROKEN INSIDE THE PATIENT 9 WEEKS POST-OP (X 4 DISTAL LOCKING SCREWS). SCREWS AND PLATES WERE REMOVED ON 5/26/23. A NIL MECHANISM OF FAILURE IS KNOWN (I.E., THE PATIENT HASN'T HAD AN ACCIDENT OR FALLEN). SCREWS AND PLATES ARE BEING CLEANED TO BE RETAINED BY THE SALES REP. THE PATIENT COMPLAINED AGAINST THE HOSPITAL WHEN THE METALWARE FAILED. THE SURGEON WANTS TO KNOW WHETHER IT IS INCORRECTLY IMPLANTED OR WHETHER THERE IS AN ISSUE WITH THE PLATE / SCREWS THEMSELVES. DISTAL RADIUS ORIF FAILURE: REMOVAL OF METAL. THE PATIENT EXPERIENCED CONSEQUENCES SUCH AS PAIN AND HEALING DELAYS. THIS REPORT IS FOR ONE (1) VA LOCKSCR Ø2.4 SELF-TAP L22 TAN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255984 VA LOCKSCR Ø2.4 SELF-TAP L22 TAN PLATE, FIXATION, BONE HRS SYNTHES GMBH 07611819980686

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention UNK - PLATES: TRAUMA| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING| UNK - SCREWS: LOCKING