BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 18351899 · Received December 18, 2023

    Report

    Report Number
    3010667733-2023-00792
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 28, 2023
    Report Date
    February 23, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD BE CONFIRMED, SINCE THE INFORMATION FOR EVALUATION MATCHES THE ALLEGED FAILURE. PROPHECY TEAM REVIEWED THE RECEIVED INFORMATION AND NOTED: CONCLUSIONS: ¿ A PARTIALLY ATTACHED BODY LOCATED ANTERIOR TO THE TIBIA WAS SEGMENTED INCORRECTLY AS A LOOSE BODY. ¿ IN CONSEQUENCE, THE TIBIA ALIGNMENT GUIDE WAS DESIGNED FOR A REFERENCE THAT DID NOT CONSIDER THE ATTACHED BODY. THEREFORE, THE ALIGNMENT GUIDE SURFACE MATCH WAS AFFECTED. ¿ IN ADDITION, THE PROPHECY PLAN STATED: ¿FOR THE PURPOSES OF GUIDE PLACEMENT, THE FRAGMENT IS INTENDED TO BE LEFT INTACT.¿ ACCORDING TO THE CT`S THIS IS CORRECT; HOWEVER, THIS GENERATED CONFUSION BECAUSE THE BODY WAS SEGMENTED AS ¿A LOOSE BODY¿ AND THE ALIGNMENT GUIDE DID NOT ACCOUNT FOR THE PRESENCE OF THE ATTACHED FRAGMENT. ¿ IN SUMMARY, THE ATTACHED BODY ANTERIOR TO THE TIBIA WAS SEGMENTED INAPPROPRIATELY AS A LOOSE BODY. ROOT CAUSE IDENTIFIED: ¿ THE TIBIA BONE MODEL WAS SEGMENTED WITHOUT THE ATTACHED BODY DUE TO HUMAN ERROR. THE SEGMENTATION REVIEWER AGREED ON THIS DECISION DURING THE "LE PROPHECY® IMAGE SEGMENTATION REVIEW¿. HOWEVER, AFTER FURTHER INVESTIGATION THE BODY NEEDED TO BE SEGMENTED AS PART OF THE TIBIA.¿ ADDITIONALLY, THE BODY WAS REPORTED INCORRECTLY, SHOWING A LOOSE BODY IN THE IMAGE, BUT REPORTED AS A PARTIALLY ATTACHED IN THE TEXT DUE TO HUMAN ERROR. INSPECTION OF THE RECEIVED INFORMATION/EVIDENCES ARE DONE OR WILL BE DONE, IN THE PROCEEDINGS OF THE NC. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE, PART #PROPINF, IS COMMERCIALLY AVAILABLE CLEARED 510K K131283. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDES DID NOT FIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDES DID NOT FIT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299145 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1773409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown