BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX

    MDR report key: 11405698 · Received March 3, 2021

    Report

    Report Number
    2939274-2021-01137
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    January 1, 2021
    Report Date
    February 8, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982066909
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2021. REPORTER IS A J&J EMPLOYEE. INVESTIGATION SUMMARY: VISUAL INSPECTION: SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX (PART # 03.008.011, LOT # 1853725, QTY#) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION AT CQ, IT IS OBSERVED THAT THE INSERTER TOP WAS LOOSE AND FALLING APART FROM THE ASSEMBLY AND THERE WERE SEVERAL DENTS ON THE INSERTER TOP COMPONENT. THE HANDLE PART SHOWS FEW SCRATCHES AND NICKS ON THE HANDLE. REST OF THE DEVICE SHOWS NORMAL WEAR WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. NO BROKEN FEATURES WERE OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. FUNCTIONAL TEST: FUNCTIONAL TESTING OF THE RECEIVED DEVICE WAS PERFORMED AT CQ. THE PLUNGER OF THE INSERTER TOP WAS TIGHT AND NOT WORKING AS INTENDED WHICH CAUSED THE INSERTER TOP TO FELL APART. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ AS THE INTERNAL COMPONENTS WERE INACCESSIBLE WITHOUT THE DESTRUCTION OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WAS REVIEWED: SPIRAL BLADE INSERTER, INSERTER TOP, SPIRAL BLADE. NO DESIGN ISSUES OR DISCREPANCIES WERE FOUND DURING THIS INVESTIGATION. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED FOR SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX (PART # 03.008.011, LOT # 1853725) AS NO BROKEN FEATURES WERE OBSERVED WITH THE RETURNED DEVICE. WHILE A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE REPORTED PROBLEM, IT IS POSSIBLE THAT THE REPEATED USE AND SERVICE MIGHT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED UPON THESE RESULTS, 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 HISTORY LOT: PART: 03.008.011, LOT: 1853725, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: APRIL 11, 2008. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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 AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT SPIRAL BLADE INSERTER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303775 SPIRAL BLADE INSERTER FOR HINDFOOT ARTHRODESIS NAIL-EX GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.008.011 1853725 10886982066909

    Patients

    Seq Age Sex Outcome Treatment
    1