BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RFNA / 11MM / 200MM STANDARD BEND / STERILE

    MDR report key: 20131454 · Received September 3, 2024

    Report

    Report Number
    8030965-2024-10647
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 7, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07612334210944
    PMA / PMN Number
    K201346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT & SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. WITHOUT THE LOT NUMBER DHR CANNOT BE PERFORMED. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 UNKNOWN SURGERY WITH RFNA FOR DISTAL FEMORAL FRACTURE. THE PAD DEVICES WERE ASSEMBLED, AND ALIGNMENT WAS ADJUSTED. THEN, THE RFNA NAIL WAS INSERTED, AND THE SURGEON FIXED THE DISTAL PART. WHEN THE NAIL PASSED THROUGH THE FRACTURE PART, A NEW FRACTURE OCCURRED. THE FRACTURE AREA WAS REDUCED MANUALLY. THE DRILL BIT INTERFERED WITH THE NAIL WHEN THE DEVICES WERE CONTROLLED THE INTERNAL OR EXTERNAL OPPOSITION AND THEN DRILLED THE MOST PROXIMAL NAIL. THE DRILL BIT WAS REMOVED FROM THE POWER TOOL. DIRECTION WAS ADJUSTED, AND DRILLING WAS PERFORMED WITH THE POWER TOOL FOR SEVERAL TIMES. THEN, SCREW FIXATION WAS COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PAD DEVICES ARE NON-JJ PRODUCTS (KSI). (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES): RFNA NAIL AND DRILL BIT. (B)(4) (KSI): PAD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RFNA / 11MM / 200MM STANDARD BEND / STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064096 RFNA / 11MM / 200MM STANDARD BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 07612334210944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNK - DRILL BITS: TRAUMA