BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXRIB STRAIGHT PLATE 2.8MM THICK/9 HOLES

    MDR report key: 8527768 · Received April 18, 2019

    Report

    Report Number
    8030965-2019-62920
    Event Type
    Injury
    Date Received
    April 18, 2019
    Date of Event
    March 20, 2019
    Report Date
    March 20, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07612334110640
    PMA / PMN Number
    K161590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    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. PART 04.501.069, LOT L914845: MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: JUNE 14, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: BOTH MATRIXRIB STERNAL PLATES PRESENT SOME DAMAGED PLATE HOLES ¿ THE THREAD IS ALMOST DRILLED OUT IN SOME HOLES, WHICH WAS CAUSED BY THE EXTRACTION INSTRUMENTS. DUE TO THE DAMAGE INCURRED THE FUNCTIONAL TEST COULD ONLY BE PERFORMED IN SOME OF THE INTACT PLATE HOLES WITH ONE OF THE RETURNED INTACT LOCKING SCREWS. THE TEST CONFIRMED THAT THE LOCKING SCREW COULD BE PROPERLY LOCKED IN THE PLATE. DIMENSIONS WERE CHECKED AT THE TIME OF MANUFACTURING WITH NO ISSUES DOCUMENTED. THE COMPLAINT CONDITION - DIFFICULTY DURING IMPLANT REMOVAL - IS CONFIRMED AS THE LOCKING SCREWS ARE BROKEN AND SOME OF THE PLATE HOLES ARE DRILLED OUT. BOTH MATRIXRIB STERNAL PLATES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE INVESTIGATION FOUND NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. MULTIPLE FACTORS CAN LEAD TO TECHNICAL DIFFICULTIES DURING REMOVAL OF LCP PLATES WITH LOCKING SCREWS. THESE FACTORS INCLUDE BUT ARE NOT LIMITED TO: WRONG TORQUE OR ANGULATION OF THE SCREW DURING INSERTION LEADING TO COLD-WELDING BETWEEN THE PLATE AND THE SCREW THREAD, OR PROTEINS WHICH ARE FORMING A BOND BETWEEN THE PLATE AND SCREW THREAD. SOME OF THESE FACTORS ARE PATIENT SPECIFIC FACTORS OR THEY DEPEND ON THE PROPER CARE OF THE SURGEON AND CAN THUS NOT BE INVESTIGATED NOR CONTROLLED BY DEPUY SYNTHES. SINCE NOT ALL OF THEM CAN BE INVESTIGATED AND EXCLUDED FROM THE ROOT CAUSE ANALYSIS, NO FINAL STATEMENT ABOUT THE CAUSE OF SUCH ISSUES DURING LCP PLATE REMOVAL CAN BE MADE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT DURING A THORACIC SURGERY DUE TO AN INFECTION ON (B)(6) 2019, UPON OSTEOSYNTHESIS METAL REMOVAL AT THE STERNUM, THE MATRIXRIB STERNAL PLATES AND SEVEN (7) LOCKING SCREWS COULD NOT BE REMOVED PROPERLY. THE SCREWHEADS WERE BROKEN WHEN UNSCREWING THE SCREWS. THE SCREWS WERE REMOVED SUCCESSFULLY BY WINDOW IN THE STERNUM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS REPORT CAPTURES THE INTRA-OP EVENT WHERE THE PLATES AND SCREWS COULD NOT BE REMOVED PROPERLY DURING HARDWARE REMOVAL PROCEDURE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POST-OP EVENT OF HARDWARE REMOVAL DUE TO AN INFECTION. THIS REPORT IS FOR ONE (1) TI MATRIXRIB STRAIGHT PLATE 2.8MM THICK/9 HOLES. THIS IS REPORT 9 OF 9 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320271 TI MATRIXRIB STRAIGHT PLATE 2.8MM THICK/9 HOLES PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L914845 07612334110640

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention