BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW BLADE STRYKER UNIV WIDE TOTAL ANKLE .500 IN

    MDR report key: 22637168 · Received July 28, 2025

    Report

    Report Number
    3010667733-2025-00871
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 30, 2025
    Report Date
    November 26, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    GFA
    UDI-DI
    00889797057219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D5 (OPERATOR OF DEVICE) FROM LAY USER/PATIENT TO OTHER (SALES REP) AND H3(DEVICE EVALUATED BY MFG). THE REPORTED EVENT COULD BE CONFIRMED BASED ON ASSESSMENT OF RETURNED DEVICE BY GQO. A VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS A PLASTIC PIECE WHICH APPEARS TO BE SHRINK WRAP STICKING ON THE SAW BLADE SURFACE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. GQO ANALYZED THE RETURNED PRODUCT AND CONFIRMED THAT THERE WAS PLASTIC SHRINK WRAP STUCK ON THE SAW BLADE SURFACE. HOWEVER, WITH THE INFORMATION GIVEN, THEY WERE UNABLE TO DETERMINE THE REASON AND CAUSE OF HOW THE PIECE OF SHRINK WRAP REACHED THERE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "UPON OPENING THIS SAW BLADE, THERE WAS ADHESIVE TAPE ON THE BLADE. SINCE WE DOUBTED THE STERILITY AND SINCE THE TAPE WAS NOT REMOVABLE, I DECIDED TO CONSIDER THIS SAW BLADE UNUSABLE." THE EVENT WAS IDENTIFIED IN THE OR WHILE THE PATIENT WAS UNDER ANESTHESIA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "UPON OPENING THIS SAW BLADE, THERE WAS ADHESIVE TAPE ON THE BLADE. SINCE WE DOUBTED THE STERILITY AND SINCE THE TAPE WAS NOT REMOVABLE, I DECIDED TO CONSIDER THIS SAW BLADE UNUSABLE." THE EVENT WAS IDENTIFIED IN THE OR WHILE THE PATIENT WAS UNDER ANESTHESIA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622463 SAW BLADE STRYKER UNIV WIDE TOTAL ANKLE .500 IN BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA WRIGHT MEDICAL TECHNOLOGY INC 1777786 00889797057219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown