BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFNA / 12MM / 280MM STANDARD BEND / STERILE

    MDR report key: 18970926 · Received March 25, 2024

    Report

    Report Number
    8030965-2024-04077
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    March 11, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982290830
    PMA / PMN Number
    K201346
    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. MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 09-JUN-2022, EXPIRATION DATE: UNKNOWN, PART NUMBER: 04.233.228S, 12MM/RFN/280MM/ 5ANG/STER/POLY INLAY, LOT NUMBER: 783P271 (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. NOTE: PER THE INSPECTION SHEET, PARTS ARE 100% CHECKED FOR INLAY DEPTH/COSMETICS. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. NOTE: SCN 69090 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 NOTATED. 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, POLY INLAY, RETROGRADE, FEMORAL LOT NUMBER: 762P088 QTY: (B)(4). PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEETS MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL WAS NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿POLYMER INLAY WAS DISCOVERED TO POPPING OUT FROM EDGE PART OF THE IMPLANT¿ DOES NOT INDICATE BREAKAGE OF THE NAIL OR ANY OF ITS COMPONENTS. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. 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

    PATIENT LISTED AS STABLE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE FEMALE PATIENT UNDERWENT ORIF WITH RFNA IMPLANT FOR FEMORAL SHAFT FRACTURE. DURING THE SURGERY, WHEN UNPACKING THE IMPLANT, A POLYMER INLAY WAS DISCOVERED TO POPPING OUT FROM EDGE PART OF THE IMPLANT. THE POLYMER INLAY WAS HAMMERED LIGHTLY TO SOMEWHAT SINK, AND A HOLE FOR A LOCKING SCREW AND ONE OF INLAY WERE ADJUSTED TO MATCH THEM EACH OTHER. UNDER INFERENCE CHECKING, A DRILL WAS CONFIRMED TO RIGHTLY PASS THROUGH THE HOLE, AND AT SURGEON¿S DISCRETION, THE IMPLANT WAS JUDGED AS AVAILABLE, SO IT WAS USED FOR INTERNAL FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN RFNA / 12MM / 280MM STANDARD BEND / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433797 RFNA / 12MM / 280MM STANDARD BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 783P271 10886982290830

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female UNK - SCREWS: LOCKING