BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT HANDLE

    MDR report key: 13908102 · Received March 25, 2022

    Report

    Report Number
    8030965-2022-01966
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    December 15, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819657342
    PMA / PMN Number
    K172872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS 1 OF 3 FOR (B)(4). 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4: LOT D9 D10: THERAPY DATE(B)(6) 21 H3, H4, H6: PART # 03.168.008 LOT # 170329-104 MANUFACTURING SITE: OBERDORF RELEASE TO WAREHOUSE DATE: NOVEMBER 29, 2017 SUPPLIER: SYNTHES GMBH 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 THE INSERT HANDLE HAD NO COSMETIC ISSUES. A DIMENSIONAL INSPECTION FOR THE INSERT HANDLE WAS UNABLE TO BE PERFORMED DUE TO DEVICES BEING STUCK TOGETHER. A FUNCTIONAL TEST WAS PERFORMED, DISASSEMBLING PROCESS WAS UNSUCCESSFUL SINCE THE DRILL BIT REMAINED JAMMED INTO THE PROTECTION SLEEVE, CAUSING FUNCTIONAL PROBLEMS WITH THE MECHANISM OF THE HANDLE. THE COMPLAINT CONDITION WAS ABLE TO BE REPLICATED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE INSERT HANDLE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. 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

    IMPLANTATION OF AN FNS. DRILLING THE LOCKING HOLE FOR INSERTING THE 5.0 LOCKING SCREW. THE DRILL GOT STUCK IN THE PROTECTION SLEEVE, FOR FEMORAL NECK SYSTEM INSERTION INSTRUMENTS. THE DR COULD NOT MOVE THE DRILL IN ANY WAY. THE FNS WAS TAKEN OUT OF THE PATIENT AND AN DHS WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010471 INSERT HANDLE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 170329-104 07611819657342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DRILL BIT Ø4.3 L413| LOCKING GUID INSERT F/INSERTION INSTR| NECK FIX BOLT L100 TAN| NECK FIX PLATE 1-HO TAN| PROTECTION SLEEVE F/INSERTION INSTR