BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM GUIDE WIRE 410MM

    MDR report key: 9643783 · Received January 29, 2020

    Report

    Report Number
    2939274-2020-00521
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    January 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982180780
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    INVESTIGATION SUMMARY: VISUAL INSPECTION: THE 1.6MM GUIDE WIRE 410MM (P/N: 292.655, LOT NUMBER: 9220291) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT IT WAS BENT IN THE MIDDLE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: SHAFT DIAMETER = 1.6 +0/-0.1 MM. MEASURED DIMENSIONS: SHAFT DIAMETER = 1.56MM, CONFORMING. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE IS BENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 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 HISTORY: PART: 292.655, LOT: 9220291, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 21.OCT.2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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 TWO (2) 1.6MM GUIDE WIRE 410MM DO NOT FUNCTION AND ONE (1) LOCKING BOLT MEASURING DEVICE F/TROCHANTERIC FIXATION NAILS WAS BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107056 1.6MM GUIDE WIRE 410MM GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 292.655 9220291 10886982180780

    Patients

    Seq Age Sex Outcome Treatment
    1