BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTTING AND BENDING PLIERS TENXOR

    MDR report key: 4131155 · Received October 1, 2014

    Report

    Report Number
    0008031020-2014-00462
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE BOLT MISSING FOR CUTTING AND BENDING PLIERS TENXOR COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. SINCE THE BOLT HOLDING THE TWO BRANCHES OF THE CUTTING AND BENDING PLIERS IS MISSING, THE ROOT CAUSE WAS ATTRIBUTED TO THE USER. TO ASSESS THE DEVICE FULLY, THE BOLT NEEDS TO BE INVESTIGATED. MOREOVER THE THREADS ON THE RESPECTIVE BRANCHES OF THE DEVICE (CUTTING AND BENDING PLIERS) SHOWS NO DEFECT. THE DEVICE MIGHT HAVE BEEN DISASSEMBLED AND THE BOLT WAS LOST. NOTE: "FOR ADEQUATE CLEANING OF MULTI-COMPONENT INSTRUMENTS, THESE MUST BE DISMANTLED ACCORDING TO THE ASSEMBLY/DISASSEMBLY INSTRUCTIONS PROVIDED BY STRYKER. PLEASE NOTE THAT STRYKER TRAYS ARE INTENDED FOR STERILIZATION, TRANSPORT AND STORAGE OF MEDICAL DEVICES. THEY ARE NOT DESIGNED FOR CLEANING AND DISINFECTION IN THE FULLY EQUIPPED STATE. THE DEVICES MUST BE REMOVED FROM THE TRAY FOR ADEQUATE CLEANING RESULTS." (V15011 REV K 01-2014 INSTRUMENTS IFU) [ORIGINAL STATEMENT] "PREVENTIVE MAINTENANCE: REGULAR FUNCTIONAL CHECK AND VISUAL INSPECTION. USE AN APPROPRIATE INSTRUMENT SPRAY FOR THE MECHANISM OF ALL MOVING PARTS AND ARTICULATING SURFACES. CHECK AND IF NECESSARY ELIMINATE ALL GAPS FOR RESIDUALS AND MOISTURE AFTER USAGE OR CLEANING. IN CASE OF FAILURE, THE INSTRUMENT MUST BE REPLACED AND NOT BE USED." (L24002000-EN REV L REPROCESSING GUIDE) A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED (BOLT) , THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION IN THE BRANCH A BOLT WAS MISSING FROM THE WIRE CUTTER PLIERS. NO PATIENT AND HOSPITAL INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION IN THE BRANCH A BOLT WAS MISSING FROM THE WIRE CUTTER PLIERS. NO PATIENT AND HOSPITAL INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612672 CUTTING AND BENDING PLIERS TENXOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH R13598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other