BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.2MM TROCAR 210MM

    MDR report key: 11725374 · Received April 26, 2021

    Report

    Report Number
    2939274-2021-02069
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 29, 2021
    Report Date
    March 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982067425
    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

    REPORTER IS A SYNTHES EMPLOYEE. PART # 03.010.070. SYNTHES LOT # 5223647. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: 04 MAY 2006. MANUFACTURED BY SYNTHES (B)(6). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE 4.2MM TROCAR 210MM (P/N: 03.010.070, LOT NUMBER: 5223647) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE DISTAL SECTION WAS BENT. DEVICE FAILURE/DEFECT IDENTIFED: YES. FUNCTIONAL TEST: A FULL FUNCTIONAL ASSESSMENT WAS UNABLE TO BE PERFORMED ON THE COMPLAINT DEVICE DUE TO NOT RECEIVING ALL THE MATING DEVICES. THE MATING DEVICES THAT WERE RETURNED WERE ABLE TO BE ASSEMBLED WITHOUT ANY ISSUES, BUT NO ALIGNMENT ISSUES COULD BE CHECKED DUE TO MISSING MATING DEVICES. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: MEASURED DIMENSIONS: DISTAL SECTION OD = CONFORMING. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED: NO. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS A COMPLETE FUNCTIONAL TEST COULD NOT BE PERFORMED. THE PARTIAL FUNCTIONAL TEST HAD NO ISSUES. HOWEVER, THE DISTAL SECTION WAS BENT. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR 1 4.2MM TROCAR 210MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624489 4.2MM TROCAR 210MM GUIDE, SURGICAL, INSTRUMENT FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.070 5223647 10886982067425

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR