BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI STERNAL LOCKING STAR PLATE 6 HOLES

    MDR report key: 17256307 · Received July 5, 2023

    Report

    Report Number
    8030965-2023-08327
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 13, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819727014
    PMA / PMN Number
    K093772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL DEVICE PRODUCT CODES: JDQ, HWC D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A (B)(6) EMPLOYEE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A TITANIUM STERNAL FIXATION SYSTEM (TSFS) WAS IMPLANTED UPSIDE DOWN. THIS WAS DONE BECAUSE THE SURGEON WAS CONCERNED ABOUT HITTING THE PATIENT¿S FACE IF HE HAD TO RE-OPERATE AND OPEN UP. THE SURGEON CHOSE TO CONTINUE THIS WAY DESPITE THE SUGGESTION THAT THE IMPLANT SHOULD BE PLACED THE OTHER WAY. THIS REPORT INVOLVES ONE TI STERNAL LOCKING STAR PLATE 6 HOLES. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785940 TI STERNAL LOCKING STAR PLATE 6 HOLES PLATE, FIXATION, BONE HRS SYNTHES GMBH 07611819727014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STERNAL LOCK-H-PL 2.4 LRG 4+4HO TAN/TICP| STERNAL LOCK-PL-2.4 STAR-SHAPED 3+3HO TA| UNK - SCREWS: TRAUMA