BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 22506034 · Received July 15, 2025

    Report

    Report Number
    3010667733-2025-00826
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    May 30, 2025
    Report Date
    October 21, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797057141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON AVAILABLE INFORMATION AND ASSESSMENT PROVIDED BY PROPHECY TEAM. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. UPON FURTHER INVESTIGATION BY THE PROPHECY TEAM, THE FOLLOWING WAS NOTED: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. THE OSTEOPHYTES IDENTIFIED ON THE TIBIA AND TALUS WERE PROPERLY SEGMENTED FOR EACH BONE, ACCORDING TO THE ANATOMY VISIBLE IN THE AVAILABLE PATIENT¿S CT-SCAN. THE ALIGNMENT GUIDES WERE DESIGNED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. THE ENGINEERING DRAWINGS AND QUALITY DOCUMENTS WERE PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ABNORMALITIES IN THE INTERNAL PROCESS WERE FOUND. ROOT CAUSE IDENTIFIED: IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE PROPHECY TIBIA GUIDE INACCURACY MENTIONED IN THE COMPLAINT¿S EMAIL. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS VS GUIDE FIT AND FEEL DURING SURGERY OR USER ERROR DURING SURGERY. ANOTHER POTENTIAL ROOT CAUSE MAY BE UNEXPECTED CHANGES ON THE PATIENT¿S ANATOMY BETWEEN THE CT-SCAN ACQUISITION DATE AND SURGERY DATE 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. HOWEVER, WITH THE AVAILABLE ASSESSMENT ROM PROPHECY TEAM SUGGESTS THAT THE ALLEGED ISSUE IS NOT RELATED TO DEVICE IF THE DEVICE IS RETURNED OR IF ANY FURTHER INFORMATION IS PROVIDED, THE COMPLAINT REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIBIAL GUIDE DIDN'T MATCH WITH THE REAL TIBIAL BONE. HOWEVER THE SURGEON MANAGED TO COMPLETE THE SURGERY SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIBIAL GUIDE DIDN'T MATCH WITH THE REAL TIBIAL BONE. HOWEVER, THE SURGEON MANAGED TO COMPLETE THE SURGERY SUCCESSFULLY. THE SURGEON STARTED THE CUTS USING THE GUIDES BUT HE HAD TO COMPLETE THEM BY HAND AND THE FINAL SIZE OF THE TIBIA WAS 3 INSTEAD 2 UNLIKE PROPHECY REPORT SUGGESTED. THERE WAS A 20 MIN SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159754 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1821222 00889797057141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown