BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25/ STERILE

    MDR report key: 17720281 · Received September 11, 2023

    Report

    Report Number
    8030965-2023-11315
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    January 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334165633
    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

    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. H4, H6 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE: 04.045.086S, LOT NUMBER: 1980P32. IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 23/09/2022, MANUFACTURING SITE:JABIL GRENCHEN, EXPIRY DATE:01/09/2032. 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: B3: ONLY THE EVENT YEAR IS KNOWN. D2B: ADDITIONAL DEVICE PRODUCT CODES: JDS, HSB. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OSTEOSYNTHESIS OF A SUPRATROCHANTERIC FRACTURE OF THE THIGH BONE VIA RFNA (RETROGRADE FEMORAL NAIL ADVANCED) WITH THE SCREW IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. ON (B)(6) 2023, IT WAS FOUND THAT THE SECOND LOCKING SCREW INSERTED FROM THE DISTAL END WAS COMING OUT. A SECOND SURGERY IS SCHEDULED TO REMOVE THE SCREW. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879425 LOCKING SCREW FOR IM NAIL Ø 5MM/ 86MM/ XL25/ STERILE SCREW, FIXATION, BONE HWC SYNTHES GMBH 1980P32 07612334165633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK - NAILS: RFNA