BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED HAMMER GUIDE CONNECTOR

    MDR report key: 12487397 · Received September 17, 2021

    Report

    Report Number
    2939274-2021-05480
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 20, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070586
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H4, H6: PART: 03.037.120 LOT: 9113198, RELEASE TO WAREHOUSE DATE: OCTOBER 02, 2014, MANUFACTURER: HAGENDORF, SUPPLIER: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE THREADED HAMMER GUIDE CONNECTOR WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, NO ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THREAD GLAND FOR CONNECTOR. CONCLUSION: THE COMPLAINT CONDITION IS UN-CONFIRMED AS NO DAMAGE WERE OBSERVED ON THE THREADED HAMMER GUIDE CONNECTOR. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J SALES REPRESENTATIVE. THE SUBJECT DEVICE IS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PHOTO INVESTIGATION: THE DEVICE WAS NOT RETURNED. UPON INSPECTING THE PHOTO PROVIDED, THE DISTAL END OF THE DRIVING CAP IS FOUND BROKEN AND EMBEDDED/LODGED INSIDE THE THREADED HAMMER GUIDE CONNECTOR. NO OTHER VISUAL DEFECTS WERE IDENTIFIED WITH THE DRIVING CAP. THE ROOT CAUSE OF THIS ISSUE CANNOT BE CONFIRMED BASED ON THE PROVIDED PHOTO. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS CONFORMING THE COMPLAINT. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. CONCLUSION: THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHOTO INVESTIGATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO MANUFACTURING ISSUES WERE NOTED DURING INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE HISTORY LOT - A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE PROVIDED. 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

    IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF A PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL USING A MALLET THE THREADED HAMMER GUIDE CONNECTOR SNAPPED OFF INSIDE THE DRIVING CAP/THREADED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) THREADED HAMMER GUIDE CONNECTOR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388961 THREADED HAMMER GUIDE CONNECTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.120 9113198 10886982070586

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP/THREADED| DRIVING CAP/THREADED| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - NAILS: TFNA| UNK - NAILS: TFNA| DRIVING CAP/THREADED| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - NAILS: TFNA