BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BLADE, CANNULATED

    MDR report key: 8107641 · Received November 27, 2018

    Report

    Report Number
    0008031020-2018-01009
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 2, 2018
    Report Date
    January 7, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    UDI-DI
    04546540361974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT THAT SCREWDRIVER BLADE, CANNULATED WAS ALLEGED OF 'BREAKAGE DURING SURGERY' COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO BE USER RELATED. THE FAILURE WAS CAUSED BY TOO HIGH TORSIONAL FORCES DURING SCREW INSERTION. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE TIP OF THE RETURNED INNER PART OF THE SCREWDRIVER IS INDEED COMPLETELY BROKEN / SHEARED OFF. THE FRACTURE SURFACE SHOWS THE APPEARANCE OF A DUCTILE FORCED RUPTURE FROM TORSIONAL OVERLOAD. THIS CLEARLY INDICATES THAT HIGH MECHANICAL FORCE HAD BEEN APPLIED DURING SCREW INSERTION (POSSIBLY HARD BONE) WHICH FINALLY RESULTED IN THE TIP BREAKAGE. SOME RESIDUES / BLOOD / CORROSION ARE ALSO CLEARLY VISIBLE. NOTE THAT THIS DEVICE WAS MANUFACTURED IN MARCH 2012 AND THEREFORE BEEN IN USE FOR SEVERAL YEARS. NOTE THAT A CORRECTIVE ACTION HAS ALREADY BEEN INITIATED IN ORDER TO FURTHER IMPROVE THE CURRENT DESIGN. THE USER MUST BE FAMILIAR WITH THE INSTRUMENTS PRIOR TO USE AND SHOULD HAVE CHECKED TO ENSURE THAT BOTH THE IMPLANT AND INSTRUMENTS USED ARE INTACT (EXTRACT FROM 90-01929 REV AA TWIN FIX INSTRUMENTS IFU). SEE DETAILS BELOW 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

    THE CUSTOMER REPORTED THAT WHEN THE SCREWDRIVER WAS USED THE INTERNAL BIT WHICH COMES OUT HAD SHEARED OFF SO WAS UNABLE TO BE USED. THE SURGEON USED THE 3MM NEW DEAL AND MANAGED TO GET COMPRESSION. DELAY IN SURGERY WAS 45 MINUTES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE SCREWDRIVER WAS USED THE INTERNAL BIT WHICH COMES OUT HAD SHEARED OFF SO WAS UNABLE TO BE USED. THE SURGEON USED THE 3MM NEW DEAL AND MANAGED TO GET COMPRESSION. DELAY IN SURGERY WAS 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948862 SCREWDRIVER BLADE, CANNULATED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER GMBH AC03 04546540361974

    Patients

    Seq Age Sex Outcome Treatment
    1 Other