BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ASNIS MICRO, HOLDING SLEEVE FOR 2.0MM SCREWS

    MDR report key: 5368059 · Received January 14, 2016

    Report

    Report Number
    0008010177-2016-00006
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 18, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 EVENT THAT 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING WAS ALLEGED OF ISSUE S-11 (BREAKAGE DURING SURGERY) COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY TOO HIGH TORSIONAL FORCES DURING CLINICAL APPLICATION, AS CONFIRMED BY THE TRANSVERSE PATTERN OF THE TIP BREAKAGE. NO SIGNS OF RUST HAVE BEEN FOUND. GIVEN THE NATURE OF THE RETURNED DEVICE, A DIMENSIONAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INSTRUCTION FOR USE (90-01972 REV E 01-2014 ASNIS MICRO INSTRUMENTS IFU_LOWRES) WAS REVIEWED AND THE FOLLOWING APPLICABLE WARNINGS HAVE BEEN IDENTIFIED: ''ENSURE THAT YOU ARE FAMILIAR WITH THE RECOMMENDED USES, COMPATIBILITY AND CORRECT HANDLING OF THE INSTRUMENT; PLEASE REMEMBER THAT PRODUCT SYSTEMS MAY BE SUBJECT TO ALTERATIONS THAT AFFECT THE COMPATIBILITY OF THE INSTRUMENT WITH OTHER INSTRUMENTS OR WITH IMPLANTS! FOR YOUR INFORMATION, AVAIL YOURSELF OF THE TRAINING COURSES AND PUBLICATIONS OFFERED BY STRYKER. SPECIAL COMMENTS FOR APPLICATION ONLY USE AN INSTRUMENT FOR ITS INTENDED PURPOSE. ALWAYS TREAT THE INSTRUMENT CAREFULLY TO AVOID SURFACE DAMAGE OR ALTERATIONS TO THE INSTRUMENT GEOMETRY. THE DESIGN OF THE INSTRUMENT MUST NOT BE MODIFIED IN ANY WAY. BEFORE EVERY OPERATION, ENSURE THAT ALL DEVICES TO BE USED DURING THE OPERATION FUNCTION CORRECTLY WITH EACH OTHER. IN THE COURSE OF THE OPERATION, REPEATEDLY CHECK THAT THE CONNECTIONS REQUIRED FOR PRECISE POSITIONING BETWEEN THE IMPLANT AND INSTRUMENTS, OR BETWEEN THE INSTRUMENTS THEMSELVES, ARE SECURE. WARNINGS AND PRECAUTIONS ALL INSTRUMENTS AND IMPLANTS SHOULD BE VERIFIED FOR PROPER FUNCTION PRIOR TO EACH CLINICAL USE. THE USER MUST BE FAMILIAR WITH THE STATE-OF-THE-ART AND THE INSTRUMENT AND IMPLANT FUNCTION PRIOR TO CLINICAL APPLICATION. " CAREFUL HANDLING AND STORAGE OF THE PRODUCT IS REQUIRED. SCRATCHING OR DAMAGE TO THE INSTRUMENTS CAN SIGNIFICANTLY REDUCE THE STRENGTH AND FATIGUE RESISTANCE OF THE PRODUCT." PLEASE NOTE THAT THIS PROBLEM HAS BEEN REPORTED THROUGH POTENTIAL (B)(4) AND IS NOW ADDRESSED BY (B)(4). A DESIGN CHANGE WILL BE IMPLEMENTED IN ORDER TO IMPROVE THE STRENGTH OF THE TIP OF THIS DEVICE. 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 OR MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT DURING SURGERY THE SCREWDRIVER IS BROKE. THE TOP OF THE SCREWDRIVER WAS DAMAGED WHILE INSERTING THE SCREW. THE BROKEN PIECES WERE RETRIEVED. THE HOSPITAL HAD ANOTHER ME SET AND THERE WAS A SCREWDRIVER WHICH FIT OUR SCREWS TO END SURGERY SUCCESSFUL

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT DURING SURGERY, THE SCREWDRIVER IS BROKE. THE TOP OF THE SCREWDRIVER WAS DAMAGED WHILE INSERTING THE SCREW. THE BROKEN PIECES WERE RETRIEVED. THE HOSPITAL HAD ANOTHER ME SET AND THERE WAS A SCREWDRIVER WHICH FIT OUR SCREWS TO END SURGERY SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26279 2.0MM ASNIS MICRO, HOLDING SLEEVE FOR 2.0MM SCREWS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG AF07

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other