BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE

    MDR report key: 18913168 · Received March 15, 2024

    Report

    Report Number
    8030965-2024-03705
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 25, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    MJG
    UDI-DI
    10705034722641
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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: D2: ADDITIONAL PROCODES: LXH, GEA, KIH D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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.

    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. H3, H4, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY REVIEW (DHR): PART# 03.804.517S-US LOT # 23I25-1 MANUFACTURING SITE: WERK SELZACH LOGISTIK SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 25 SEP 2023 EXPIRATION DATE: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED 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

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PRODUCT BROKE OFF IN THE PATIENT LEAVING METAL IN THE PATIENT¿S L5 PEDICLE. THE PATIENT IS RECOVERING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE. THIS IS REPORT 6 OF 6 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471226 ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE DEVICE, PERCUTANEOUS, BIOPSY MJG SYNTHES GMBH 23I25-1 10705034722641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ACCES KIT 10 GAGE-BEVEL TIP SIDE-OPEN-ST| ACCES KIT 10 GAGE-BEVEL TIP SIDE-OPEN-ST| ACCES KIT 10 GAGE-BEVEL TIP SIDE-OPEN-ST| ACCESS KIT 10 G DIAM TIP W/END-OPEN SING| ACCESS KIT 10 G DIAM TIP W/END-OPEN SING