BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE

    MDR report key: 10907626 · Received November 26, 2020

    Report

    Report Number
    8030965-2020-09225
    Event Type
    Injury
    Date Received
    November 26, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 30, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2020. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 HISTORY LOT: MANUFACTURING DATE: 21-NOV-2019, EXPIRATION DATE: 01-NOV-2029, PART NUMBER: 04.037.014S, 10MM/125 DEG TI CANN TFNA 235MM/RIGHT ¿ STERILE, LOT NUMBER: 26P6320 (STERILE). ONE PIECE WAS SCRAPPED IN CELL AT OP #140, QA FINAL INSPECT, FOR SURFACE FINISH DINGS / SCRATCHES. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, IN-PROCESS / INSPECT DIMENSIONAL / FINAL, NS500294059 REV A MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED. INSPECTION SHEET, TFNA ASSEMBLY INSPECTION, NS067861 REV B MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AD WAS REVIEWED AND INDICATES THAT THERE IS A LABEL COUNT DISCREPANCY. THE PLL INDICATES THAT 6 LABELS WERE PLACED ON PRODUCT, 1 LABEL ON THE PLL AND 2 LABELS WERE DESTROYED. THIS LOT CONTAINED 5 PIECES. THEREFORE, THERE IS 1 LABEL UNACCOUNTED FOR. THIS DISCREPANCY WILL REQUIRE ADDITIONAL INVESTIGATION. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN (B)(4) SUPPLIED BY ETHICON (ABQ) WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND STERILITY CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION OF ¿REMOVAL DUE TO CUT-OUT¿ DOES NOT INDICATE BREAKAGE OF THE NAIL OR ANY OF ITS COMPONENTS. THEREFORE, A REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. DEVICE HISTORY REVIEW THIS LOT MET ALL DIMENSIONAL, VISUAL AND STERILITY CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH THE TFNA IN QUESTION. ON AN UNKNOWN DATE, THE SURGEON CONFIRMED THAT CUT-OUT OCCURRED. ON (B)(6) 2020, THE PATIENT UNDERWENT THE REVISION SURGERY AND IN THE REVISION, THE SURGEON REMOVED TFNA AND PERFORMED BHA SURGERY. THE SURGEON COMMENTED THAT THERE WAS NO PROBLEM ABOUT TFNA, AND THE ORIGINAL FRACTURE WAS UNSTABLE WHICH CAUSED THE CUT-OUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376092 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH 26P6320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention