BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE WIRE HANDLE CHUCK T2 TIBIA Ø2-3,5 MM

    MDR report key: 3092547 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00236
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. EVALUATION REVEALED BOTH INSTRUMENTS TO BE PRIMARY PRODUCTS. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICES HAD BEEN IN USE FOR MORE THAN 3 YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE RETURNED INSTRUMENTS ARE NOT FUNCTIONAL BECAUSE THE GUIDE WIRE CAGE (1806-0098) AND THE CLAMPING SLEEVE (1806-099) ARE MISSING. THE GUIDE WIRE CAGE IS DESIGNED TO BE REMOVABLE FOR CLEANING AND STERILIZATION (BAYONET COUPLING). THIS ALLOWS ALSO REMOVING THE CLAMPING SLEEVE. BOTH COMPONENTS MUST BE ASSEMBLED PRIOR TO SURGERY TO GUARANTEE FUNCTIONALITY. HOWEVER, THE RETURNED INSTRUMENTS ARE FULLY FUNCTIONAL. THE MISSING COMPONENTS ARE A RESULT OF AN IMPROPER STORAGE AND/OR AN IMPROPER HANDLING AND ARE NOT MANUFACTURER RELATED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE HANDLE WAS MISSING A SPRING AND COULD NOT SECURE WITHOUT THE GUIDE WIRE HANDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE HANDLE WAS MISSING A SPRING AND COULD NOT SECURE WITHOUT THE GUIDE WIRE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194863 GUIDE WIRE HANDLE CHUCK T2 TIBIA Ø2-3,5 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL K175448

    Patients

    Seq Age Sex Outcome Treatment
    1 Other