BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING

    MDR report key: 4729735 · Received April 27, 2015

    Report

    Report Number
    0008010177-2015-00089
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    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 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING WAS ALLEGED OF ISSUE S-36 (COMPONENT / DEVICE STUCK) COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY THE PRESENCE OF SOME BIO-RESIDUES BETWEEN THE CANNULATED DRILL AND THE K-WIRE. ONCE REMOVED MANUALLY, THE K-WIRE AT ISSUE COULD SUCCESSFULLY PASS THROUGH THE CANNULATED DRILL. PLEASE NOTE THAT THE INSTRUCTION FOR USE (90-01972 REV E 01-2014 ASNIS MICRO INSTRUMENTS IFULOWRES) STATES THE FOLLOWING: USERS HAVE TO ENSURE THE CLEANLINESS OF THE CANNULATION OF THE INSTRUMENT PRE-, INTER- AND POST OPERATIVELY TO MAKE SURE THAT BONE DEBRIS DOES NOT ACCUMULATE AND TO REDUCE THE RISK OF INSTRUMENTS BINDING ON THE GUIDE WIRE. ONCE APPLIED, SINGLE USE PRODUCTS SHOULD NEVER BE REUSED AND THEREFORE MUST BE DISCARDED AT THE END OF A SURGICAL PROCEDURE, EVEN IF THEY APPEAR TO BE UNDAMAGED.¿ THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICES RESULTED STUCK ONE IN THE OTHER. THE CANNULATED DRILL DIDN'T SHOW ANY ANOMALIES. THE DIMENSION IMPORTANT FOR THIS COMPLAINT (INNER CANNULATION DIAMETER) HAS BEEN MEASURED AND RESULTED ACCORDING TO DRAWING SPECIFICATIONS (RANGE 1.22MM÷1.32MM) SOME BIO-RESIDUES HAVE BEEN FOUND TO CAUSE THE JAM BETWEEN THE TWO DEVICES. ONCE REMOVED MANUALLY, THE K-WIRE AT ISSUE COULD SUCCESSFULLY PASS THROUGH THE CANNULATED DRILL. 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 ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING ASNIS MICRO SURGERY, K-WIRE COULD NOT BE REMOVED FROM DRILL AFTER DRILLING. THE SURGEON USED ANOTHER NEW K-WIRE AND DRILL.

    Description of Event or Problem · 1

    DURING ASNIS MICRO SURGERY, K-WIRE COULD NOT BE REMOVED FROM DRILL AFTER DRILLING. THE SURGEON USED ANOTHER NEW K-WIRE AND DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275203 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER LEIBINGER FREIBURG AE03/EA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other