BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATNEU SCR ø1.5 SELF-DRILL L4 TAN 4U I/C

    MDR report key: 17700251 · Received September 7, 2023

    Report

    Report Number
    8030965-2023-11254
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 21, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    UDI-DI
    07611819901643
    PMA / PMN Number
    K123723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H6: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 04.503.104.04S LOT NUMBER: 4462P12 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 15/02/2023 MANUFACTURING SITE:JABIL BETTLACH EXPIRY DATE:01/02/2033 . 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 · 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: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E1: FACILITY PHONE (B)(6). E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE H3, H6: 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 JAPAN AS FOLLOWS: IT WAS REPORTED AN UNKNOWN SURGERY FOR BRAIN ANEURYSM WAS PERFORMED ON (B)(6) 2023. THE ASSOCIATED SCREWS IN QUESTION WERE PLACED IN THE INSTRUMENT CASE. WHEN THE UPPER LID WAS REMOVED, THE SCREWS STUCK TO THE UPPER LID. ALTHOUGH THE SCREWS ALMOST FELL TO THE FLOOR, THEY DID NOT BECOME UNCLEAN THIS TIME. EVEN THOUGH THE SURGEON AND THE NURSE CAREFULLY OPERATED THE SCREWS, THEY STUCK TO THE UPPER LID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A MINUTE SURGICAL DELAY. PATIENT IS LISTED AS STABLE. IT WAS NOTED SIMILAR CASES HAVE BEEN REPORTED IN (B)(4) AND (B)(4) WHEN INTERVIEWING NURSES RECENTLY, ABOUT 10 NURSES EXPERIENCED THE SAME ISSUE. THIS REPORT IS FOR ONE SELF DRILL L4 SCREW FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293827 MATNEU SCR ø1.5 SELF-DRILL L4 TAN 4U I/C PLATE, BONE JEY SYNTHES GMBH 4462P12 07611819901643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown