BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL SLEEVE, LOCKING Ø3.1MM, SHORT

    MDR report key: 8705175 · Received June 17, 2019

    Report

    Report Number
    0008031020-2019-00631
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    07613327083606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY CLEAR MISUSE OF THE INSTRUMENTS. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE CUTTING EDGES OF THE RETURNED DRILL BIT IS INDEED COMPLETELY GONE AND BLUNT. ALSO THE CANNULATIONS OF BOTH DRILL SLEEVES ARE INDEED BADLY DAMAGED / DEFORMED. CLOSE-UP IMAGES (USING THE MICROSCOPE) OF THE DRILL BIT CLEARLY SHOW THAT THE DRILL WAS SURELY USED ON AN ANGLE. AS THE METAL SHAFT HAS BEEN GRINDED OFF SEVERELY (MISUSE). DUE TO THESE DAMAGES, THE DRILL WOULD NOT PASS THE CANNULATION ON EITHER DRILL SLEEVE ANY MORE. TEST USING A NEW DRILL BIT WERE IDENTICAL, ALL THREE INSTRUMENTS ARE UNUSABLE. 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 · 0

    IT WAS REPORTED THAT WHEN THE DRILLING WAS DONE WITH DRILL BIT AND DRILL SLEEVE, THE METALLIC SOUNDED AND THE DRILL DID NOT ADVANCE FURTHER. THEREFORE, THE DRILL WAS CHANGED THE NEW ONE BUT THE SAME EVENT WAS OCCURRED. THEREFORE, THE SLEEVE WAS CHANGED AND THE OPERATION WAS CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DRILLING WAS DONE WITH DRILL BIT AND DRILL SLEEVE, THE METALLIC SOUNDED AND THE DRILL DID NOT ADVANCE FURTHER. THEREFORE, THE DRILL WAS CHANGED THE NEW ONE BUT THE SAME EVENT WAS OCCURRED. THEREFORE, THE SLEEVE WAS CHANGED AND THE OPERATION WAS CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497235 DRILL SLEEVE, LOCKING Ø3.1MM, SHORT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH K0A8E6D 07613327083606

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR