BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES

    MDR report key: 10600030 · Received September 29, 2020

    Report

    Report Number
    2939274-2020-04371
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 5, 2020
    Report Date
    September 5, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTJ
    UDI-DI
    10886982072818
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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, H6: PART: 03.113.014, LOT: 8581991, MANUFACTURING SITE: HAEGENDORF, RELEASE TO WAREHOUSE DATE: DECEMBER 09, 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES AND 1.6MM PERCUTANEOUS THREADED WIRE GUIDE WERE RECEIVED ASSEMBLED AT CUSTOMER QUALITY (CQ). BOTH DEVICES WERE FOUND STUCK/ LOCKED, IT WAS NOT ABLE TO DISASSEMBLE/SEPARATE MATING DEVICE. HENCE, THE COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING: MULTIPLE ATTEMPTS WERE TRIED TO SEPARATE THE BOTH THE DEVICES. BUT, THEY WERE NOT ABLE TO BE SEPARATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS STUCK FEATURES WERE INACCESSIBLE WITHOUT DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: ADAPTER MIT GRIFF M5 GUIDEHANDLE M5 KPL 163.5 LCP AIMING SYSTEMS CONCLUSION: THE COMPLAINT IS PARTIALLY CONFIRMED. A DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (DURING USAGE OR HANDLING AT THE TIME OF SURGERY) WHICH MAY LED DEVICES TO BE JAMMED. DURING THE INVESTIGATION, NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 DURING A TIBIAL PLATEAU CASE ON (B)(6) 2020, THE UNKNOWN AIMING ARM AND THE 1.6 MM THREADED WIRE GUIDE WAS FUSED TOGETHER WITH THE HANDLE FOR DRILL SLEEVES AND COULD NOT BE ABLE TO GET THOSE PIECES APART WHICH EACH OTHER. THE ISSUE CAUSED A SMALL DELAY TO THE PROCEDURE. ANOTHER DEVICE WAS USED ON THE CASE. PATIENT STATUS AND SURGICAL OUTCOMES WAS SUCCESSFUL. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064375 HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES GAUGE,DEPTH HTJ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.113.014 8581991 10886982072818

    Patients

    Seq Age Sex Outcome Treatment
    1 1.6MM PERCUTANEOUS THREADED WIRE GUIDE| UNK - GUIDES/SLEEVES/AIMING: GUIDE