BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL NECK SYSTEM INSERTION HANDLE

    MDR report key: 13309670 · Received January 20, 2022

    Report

    Report Number
    8030965-2022-00455
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 27, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819657342
    PMA / PMN Number
    K172872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    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. H3, H4, H6: PART # 03.168.008, LOT # 170329-101, MANUFACTURING SITE: SYNTHES SELZACH, RELEASE TO WAREHOUSE DATE: DECEMBER 11, 2017, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT INSERT HANDLE THAT IT HAD NO DEFECT FOUND ON IT. THE FUNCTIONAL TEST WAS PERFORMED WITH THE MATING DEVICE THAT WAS ALSO RETURNED INS F/INSERTION HANDLE AND THEIR FUNCTION WAS PERFORMED PROPERLY. THE BLACK SCREW WAS COMPLETELY TIGHTEN ON THE MATING DEVICE THREAD. NO OTHER ISSUE WAS FOUND ON THE DEVICE. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO DEVICE DESIGN. A FUNCTIONAL TEST WAS PERFORMED. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED, THE DEVICES COMPLIED WITH ITS FUNCTION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR INSERT HANDLE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION FOR THE FEMORAL NECK FRACTURE WITH THE FNS. THE NURSE TRIED TO TIGHTEN THE BLACK SCREW OF THE INSERT FOR ATTACHING THE IMPLANT ONTO THE INSERTION HANDLE, BUT IT WAS STIFF TO TIGHTEN. THE BLACK SCREW OF THE INSERT WAS TIGHTENED WITH FORCEPS CAREFULLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT INVOLVES ONE (1) FEMORAL NECK SYSTEM INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80494 FEMORAL NECK SYSTEM INSERTION HANDLE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 170329-101 07611819657342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown INS F/INSERTION HANDLE| UNK - SCREWS: TRAUMA