BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM

    MDR report key: 3942676 · Received July 17, 2014

    Report

    Report Number
    3009450863-2014-10025
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SYNTHES BALSTHAL
    Product Code
    LRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE AWARE DATE FOR THIS REPORT REFLECTS THE DATE THE ADDITIONAL (B)(4) PARTS WERE RECEIVED BY SYNTHES AS PART OF THE EXISTING COMPLAINT RECEIVED ON (B)(4) 2014. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NONCONFORMANCE 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION AND A MANUFACTURING EVALUATION WERE COMPLETED: THE 19 K-WIRES WERE RETURNED IN A DAMAGED STATE WITH VARYING AMOUNTS OF SCRATCHES. (B)(4) PARTS SHOWED NO DAMAGE AT ALL. (B)(4) PARTS SHOWED MINIMAL DAMAGE, WHICH MAY BE THE RESULT OF A NORMAL USE. (B)(4) PARTS WERE HEAVILY DAMAGED. THE COLIBRI DEVICE MENTIONED IN THE COMPLAINT WAS NOT PROVIDED. THE HEAVILY DAMAGED K-WIRES SUGGEST THAT THESE PARTS WERE MISUSED. WRONG POWER TOOL CLAMPING SETTING, NOT ENOUGH MANUAL PRESSURE OR MULTIPLE USE OF THESE SINGLE-USE ITEMS ARE MOST LIKELY. IT IS MENTIONED IN THE COMPLAINT THAT K-WIRES AND TOOLS OF MULTIPLE COMPANIES ARE BEING USED AT THIS SITE. WITHOUT KNOWLEDGE OF WHICH INSTRUMENT WAS USED WITH WHICH K-WIRE A CLOSER INVESTIGATION IS NOT POSSIBLE. FURTHER INVESTIGATION REGARDING THE MANUFACTURING AND RAW MATERIAL DOCUMENTS SHOWS CONFORMITY TO THE SPECIFICATION AS WELL. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE QUICK COUPLING GETTING METAL PARTICLES AFTER CLEANING. THE PRODUCT WAS USED WITH BOTH SYNTHES AND NON-SYNTHES K-WIRES. THE NON-SYNTHES COMPANIES ARE ALSO BEING CONTACTED ABOUT THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 13 OF 20 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418174 2.5MM DHS/DCS GUIDE WIRE W/THREADED TIP 230MM WIRE,SURGICAL LRN SYNTHES BALSTHAL 8955250

    Patients

    Seq Age Sex Outcome Treatment
    1