BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM/2.0MM WIRE GUIDE 140MM

    MDR report key: 6087982 · Received November 8, 2016

    Report

    Report Number
    2530088-2016-10310
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: PART# 03.010.087 , SYNTHES LOT# 5042291, RELEASE TO WAREHOUSE DATE: 10-AUG-2005, MANUFACTURED BY SYNTHES (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THESE FIELDS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE FOLLOWING TWO (2) DEVICES (ONE (1) 8.0MM/2.0MM WIRE GUIDE, 140MM (PART NUMBER 03.010.087 / LOT NUMBER 5042291) AND ONE (1) 2.0MM TROCAR, 150MM (PART NUMBER 03.010.088 / LOT NUMBER 5037674) WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DEVICE INTERACTION: DOES NOT FIT WITH OTHER PARTS.¿ IT WAS REPORTED THAT THE WIRE GUIDE WAS NOT ACCEPTING 2.0MM GUIDE WIRE FOR INSERTION OF SPIRAL BLADE IN AN EX HUMERUS NAIL. THE SURGEON SPENT ROUGHLY 5 MINUTES ATTEMPTING TO CLEAR WIRE GUIDE OF IMPEDIMENT INCLUDING ATTEMPTING TO PUSH THE 2.0 MM TROCAR THROUGH. HE WAS UNSUCCESSFUL AND PROCEEDED TO INSERT THE SPIRAL BLADE IN A FREE HAND FASHION WITHOUT CONSEQUENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE TROCAR AND WIRE GUIDE WERE EACH RECEIVED INTACT WITH SURFACE WEAR CONSISTENT WITH SIGNIFICANT USE. THE DISTAL END OF THE TROCAR SHOWS SLIGHT BENDING. THIS DAMAGE IS CONSISTENT WITH THE RESULT FROM THE REPORTED USE OF ATTEMPTING TO CLEAR THE WIRE GUIDE CANNULATION BY PUSHING THE TROCAR THROUGH. THE DEVICES COULD BE ASSEMBLED BUT SIGNIFICANT RESISTANT WAS ENCOUNTERED. INSPECTION WITH GAGE PINS OF THE DISTAL PORTION OF THE WIRE GUIDE, WHERE THE CANNULATION NARROWS, WAS PERFORMED. IT WAS DETERMINED THAT THE LARGEST ALLOWABLE GAGE PIN WAS 1.92MM WHICH IS OUTSIDE THE SPECIFICATION OF 2.1MM +/-0.05 AND WOULD RESULT IN INTERFERENCE WITH THE INTENDED GUIDE WIRE. (GAGE PINS: GP32/GP29) THUS, THE COMPLAINT CONDITION IS CONFIRMED, CONSISTENT WITH THE REPORTED CONDITION, AND CAN BE REPLICATED. A ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE CARE AND MAINTENANCE DURING THE DEVICES APPROXIMATELY 11+ YEAR LIFESPAN IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. 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 SURGEON WAS PERFORMING A PROPHYLACTIC NAIL INSERTION PROCEDURE ON (B)(6) 2016 AND THE WIRE GUIDE WAS NOT ACCEPTING 2.0MM GUIDE WIRE FOR INSERTION OF SPIRAL BLADE IN AN EX HUMERUS NAIL. THE SURGEON SPENT ROUGHLY 5 MINUTES ATTEMPTING TO CLEAR WIRE GUIDE OF IMPEDIMENT INCLUDING ATTEMPTING TO PUSH THE 2.0 MM TROCAR THROUGH. HE WAS UNSUCCESSFUL AND PROCEEDED TO INSERT THE SPIRAL BLADE IN A FREE HAND FASHION WITHOUT CONSEQUENCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738547 8.0MM/2.0MM WIRE GUIDE 140MM N/A LXH SYNTHES BRANDYWINE 5042291

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR