BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM GUIDE WIRE 400MM

    MDR report key: 19425982 · Received May 30, 2024

    Report

    Report Number
    8030965-2024-06865
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 30, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). 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. E3: REPORTER IS A J&J SALES REPRESENTATIVE. INVESTIGATION SUMMARY: 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. H3/H6: DEVICE HISTORY LOT PART # 357.399S. LOT # 225L078. MANUFACTURING SITE: WERK SELZACH LOGISTIK . RELEASE TO WAREHOUSE DATE: 11 SEP 2023. EXPIRATION DATE: 01 SEP 2033. SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 357.399. NON-STERILE LOT # 7461P80. MANUFACTURING SITE: DEPUY SYNTHES PRODUCTS, INC. RELEASE TO WAREHOUSE DATE: 11 AUG 2023. SUPPLIER: (B)(4). 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 PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A FEMORAL NECK FRACTURE. WHEN THE GUIDE WIRE WAS INSERTED USING A POWER TOOL, THE GUIDE WIRE TIP STOPPED ADVANCING SHORTLY AFTER IT WAS INSERTED INTO THE BONE ALTHOUGH THE POWER TOOL WAS WORKING PROPERLY. THE SURGEON REMOVED THE GUIDE WIRE ONCE AND STARTED INSERTING ANOTHER NEW GUIDE WIRE WITH THE POWER TOOL. THAT NEW GUIDE WIRE WAS INSERTED SMOOTHLY WITH NO PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR ONE (1) 3.2MM GUIDE WIRE 400MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285514 3.2MM GUIDE WIRE 400MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 225L078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown