BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE NITINOL 10 X 10 FUSEFORCE

    MDR report key: 15262454 · Received August 19, 2022

    Report

    Report Number
    0001043534-2022-00004
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 25, 2022
    Report Date
    December 5, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    JDR
    UDI-DI
    00840420127327
    PMA / PMN Number
    K124045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE NUMBER IN G8 SHOULD START WITH (B)(4). THE REPORTED EVENT COULD BE CONFIRMED, SINCE THE DEVICE WAS RETURNED AND EXAMINATION FOUND THE PLASTIC AROUND THE DRILL SLEEVES TO BE CRACKED AND DAMAGE/DEFORMATION ON THE SHAFT OF THE DRILL BIT. THE DEVICE INSPECTION REVEALED THE FOLLOWING: EXAMINATION FINDS THE PLASTIC AROUND THE GUIDE SLEEVES IS CRACKED. DAMAGE TO THE DRILL SHAFT DISTAL THE FLUTING WAS ALSO VISIBLE INDICATING THE DRILL WAS MOST LIKELY MOVED OFF AXIS WHILE INSIDE THE SLEEVE. STRIATIONS WERE FOUND NEAR THE BOTTOM DISTAL END OF THE HANDPIECE THAT ARE CONSISTENT WITH A DOWNWARD FORCE WHILE DRILL IS UNDER LOAD. FUNCTIONAL INSPECTION: FUNCTIONAL TEST FOUND THAT A TEST DRILL WAS ABLE TO SLIDE IN AND OUT OF BOTH DRILL SLEEVE (151781) THROUGH HOLES WITHOUT ISSUE. KEY DIMENSIONAL MEASUREMENTS WERE TAKEN OF THE DRILL AND SLEEVE AND ALL WERE FOUND TO BE WITHIN SPECIFICATIONS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE FAILURE WAS CAUSED BY THE DRILL BEING TOGGLED WHILE INSIDE THE DRILL SLEEVE. 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 MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL BIT COLD WELDED TO DRILL GUIDE OF A 10X10 FUSEFORCE STAPLE. THERE WAS A DELAY OF ABOUT 5 MINUTES DURING THE PROCEDURE. WHEN THE STAPLE KIT FAILED, THE SURGEON UTILIZED A 2.0 CANNULATED SCREW TO SALVAGE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL BIT COLD WELDED TO DRILL GUIDE OF A 10X10 FUSEFORCE STAPLE. THERE WAS A DELAY OF ABOUT 5 MINUTES DURING THE PROCEDURE. WHEN THE STAPLE KIT FAILED, THE SURGEON UTILIZED A 2.0 CANNULATED SCREW TO SALVAGE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942136 STAPLE NITINOL 10 X 10 FUSEFORCE STAPLE, FIXATION, BONE JDR WRIGHT MEDICAL TECHNOLOGY INC FFNS1010 1704776 00840420127327

    Patients

    Seq Age Sex Outcome Treatment
    1 Female