BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUNTER TENDON ROD 3MM X 24.5CM

    MDR report key: 14749070 · Received June 20, 2022

    Report

    Report Number
    3010667733-2022-00215
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 17, 2022
    Report Date
    August 30, 2022
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HXR
    UDI-DI
    00840420128942
    PMA / PMN Number
    K853436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE RETURNED DEVICE IS CONFORMING TO SPECIFICATIONS AND FULLY FUNCTIONAL. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEVICE WAS RETURNED IN THE ORIGINAL CARTON. THE CARTON CONFIRMED THE CATALOG TO BE TR300000 AND LOT TO BE 1709893. THE CARTON WAS OPENED AND INSIDE THE HUNTER TENDON WAS IN THE INNER TYVEK POUCH IN AN OPENED STATE. THE LABEL ON THE INNER TYVEK POUCH ALSO CONFIRMS THE CATALOG AND LOT NUMBER. THE HUNTER TENDON WAS WHITE AND DID NOT EXHIBIT ANY ABNORMAL DAMAGE OR DEFORMATION. DIMENSIONAL MEASURMENTS TAKEN FOUND THE RETURNED DEVICE TO BE WITHIN SPECIFICATIONS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. 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 DURING THE PROCEDURE THAT THERE WAS A DISCREPANCY IN THE SIZE OF IMPLANT VS THE SIZE LISTED ON THE BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE PROCEDURE THAT THERE WAS A DISCREPANCY IN THE SIZE OF IMPLANT VS THE SIZE LISTED ON THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043786 HUNTER TENDON ROD 3MM X 24.5CM SPATULA, ORTHOPEDIC HXR WRIGHT MEDICAL TECHNOLOGY INC TR300000 1709893 00840420128942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown