BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES

    MDR report key: 16421819 · Received February 22, 2023

    Report

    Report Number
    8030965-2023-02188
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 9, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819889439
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. PROCODES: HRS, JDQ. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INITIAL REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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 DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING A PROCEDURE, THE SCREWS USED WERE NOT COMPATIBLE WITH THE PLATE HOLES. THE SCREW HEAD COULD NOT BE FULLY SCREWED INTO THE PLATE HOLE. STEEL WIRES WERE USED IN THE STERNUM LOCK WHICH FURTHER STABILIZED THE BAR TO THE STERNUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES. THIS IS REPORT 4 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135558 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES SCREW, FIXATION, BONE HWC SYNTHES GMBH 07611819889439

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male MATRIXMAND RECO-PL DBL-ANGL LRG T2.5 TI.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.| STERNAL UNILOCK-SCR Ø3 SELF-TAP CRUCIFOR.