BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFNA / 12MM / 340MM 5 DEGREE BEND / STERILE

    MDR report key: 18884893 · Received March 12, 2024

    Report

    Report Number
    8030965-2024-03510
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 24, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K201346
    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. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 26-MAY-2023, EXPIRATION DATE: UNKNOWN, PART NUMBER: 04.233.234S, 12/MM/RFN/340MM/5ANG/STER/POLY INLAY, LOT NUMBER: 766P906 (STERILE), LOT QUANTITY: (B)(4). PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, RFN ASSEMBLY INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN 68910 WAS RECORDED ON THE PRODUCTION ORDER TRAVELER. THE SCN WAS REVIEWED AND MET SPECIFIED DOSE RANGES HOWEVER, THERE WAS NO LINKAGE TO SPECIFIC LOT NUMBERS WITHIN THE DOCUMENT. THERE WAS NO PLL INCLUDED IN THIS DHR. THEREFORE, THE PLL FOR THIS LOT COULD NOT BE REVIEWED AND THE EXPIRATION DATE COULD NOT BE NOTED. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 04.233.124.2Y, LOT NUMBER: 741P866, QTY: (B)(4). PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET MET ALL INSPECTION ACCEPTANCE CRITERIA. NOTE: INSPECTION SHEET INDICATES THAT OUTER DIAMETER WAS 100% INSPECTED AND NO DEFECTS WERE NOTED. RAW MATERIAL REVIEWED: MATERIAL NUMBER: 21131, TIALV*RI13.00, LOT NUMBER: 732P720, QTY: (B)(4). INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFIED TEST REPORT SUPPLIED BY PERRYMAN COMPANY WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING / PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. 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: D2: ADDITIONAL PROCODE: HWC 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE RFNA NAIL IMPLANT FOR A LEFT FEMORAL SHAFT FRACTURE. DURING THE PROCEDURE WHEN THE NAIL IMPLANT WAS UNPACKED, A POLYMER INLAY WAS FOUND TO BE POPPING OUT. THE NAIL WAS THE CORRECT FITTING SIZE, NO OTHER NAILS WERE ROLLED OUT, SO THE POLYMER INLAY WAS ADJUSTED TO THE CORRECT LOCATION USING FORCEPS. UPON DRY CHECKING, A DRILL WAS FOUND TO BE ABLE TO PASS THROUGH THE NAIL SO INSERTION WENT FORWARD UNDER THE SURGEON¿S DISCRETION. THE DRILL WAS ALSO OBSERVED TO NOT INTERFERE IN THE PATIENT¿S BODY, SO THE SURGICAL INCISION WAS CLOSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 30 MINUTES. NO FRAGMENTS WERE GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN RFNA / 12MM / 340MM 5 DEGREE BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910647 RFNA / 12MM / 340MM 5 DEGREE BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 766P906

    Patients

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