BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING

    MDR report key: 4062422 · Received September 5, 2014

    Report

    Report Number
    0008031020-2014-00414
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    THE REPORTED INCIDENT THAT EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING WAS ALLEGED OF ISSUE S-18 (INSTRUMENT BREAKAGE IDENTIFIED OUT OF SURGERY) COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY INADEQUATE MAINTENANCE OF THE DEVICE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: TIP BREAKAGE COULD BE CONFIRMED. BROADLY SPEAKING, THE DEVICE APPEARED IN GOOD CONDITION, BUT SOME RUST WAS IDENTIFIED ON THE BREAKAGE SURFACE. PLEASE NOTE THAT THE CLEANING AND STERILIZATION GUIDE (L24002000-EN REV. M, OT-RG-1 REV. 1 CLEANING AND STERILIZATION GUIDE) REPORTS THE FOLLOWING: ''THE GUIDANCE CONCENTRATIONS AND TIMES FOR DEVICE IMMERSION IN THE CLEANING SOLUTIONS AND/OR DISINFECTANTS GIVEN BY THE DETERGENT MANUFACTURERS SHALL BE OBSERVED. IF THESE CONCENTRATIONS AND TIMES ARE EXCEEDED SIGNIFICANTLY, DISCOLORATION OR CORROSION COULD OCCUR WITH SOME MATERIALS. THIS COULD ALSO HAPPEN IF RINSING AFTER CLEANING AND/OR DISINFECTING IS INSUFFICIENT." 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. GIVEN THE HIGH FREQUENCY OF THIS FAILURE MODE, THIS CASE HAS BEEN PRESENTED TO R&D DEPARTMENT, WHICH ANALYSES THE EVENT AND PROVIDED THE FOLLOWING STATEMENT "A SUCCESSFUL USAGE OF THE EXTRACTOR CANNOT BE GUARANTEED NOT HAS IT BEEN VALIDATED BECAUSE THE IMPLANT TO BE REMOVED DOES NO LONGER REFLECT THE IMPLANT DESIGN OF THE SALABLE ITEM. ADDITIONAL FACTORS BESIDES THE MISSING GEOMETRICAL FITTING INFLUENCING THE REMOVAL CHANCE WITH THE EXTRACTOR DEVICE ARE ALSO THE BONE HARDNESS, GRADE OF BONY INGROWN, ACCESSIBILITY OF THE IMPLANT, SURROUNDING LIGAMENTS, MUSCLES, TENDONS, SOFT TISSUE, ETC. THESE FACTORS ARE DIFFERENT FROM CASE TO CASE AND SOMETIMES DIFFICULT TO ASSESS (BONE QUALITY) AT THE TIME OF THE EMERGENCY REMOVAL. TO CONCLUDE: A FAILURE OR EVEN DAMAGE OF THE EMERGENCY INSTRUMENTS IS TAKEN INTO CONSIDERATION AS IT IS AT THIS STAGE THE LAST RESORT FOR AN IMPLANT REMOVAL WITHOUT FURTHER DESTRUCTION OF THE IMPLANT ITSELF OR RESECTION OF THE SURROUNDING BONE AND SOFT TISSUE. A HIGHER BREAKAGE RATE OF EXTRACTION INSTRUMENTS AND THUS THE ASNIS III EXTRACTOR IS ACCEPTABLE. NO DESIGN CHANGE IS NECESSARY AT THIS TIME." IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF EXTRACTOR BROKE. ACCORDING TO SALES REP, THE PROBLEM WAS NOT SEEN DURING THE OPERATION.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF EXTRACTOR BROKE. ACCORDING TO SALES REP, THE PROBLEM WAS NOT SEEN DURING THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544635 EXTRACTOR ASNIS III FOR SCREWS:Ø4.0MM AO FITTING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH H18318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other