BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 21954018 · Received May 2, 2025

    Report

    Report Number
    3010667733-2025-00525
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 10, 2025
    Report Date
    July 21, 2025
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797057141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

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

    Additional Manufacturer Narrative · 0

    CORRECTED FIELD: PRODUCT AVAILABLE TO STRYKER (D9) AND CLINICAL SIGNS CODE GRID (H6). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. UPON FURTHER INVESTIGATION BY THE PROPHECY TEAM, THE FOLLOWING WERE NOTED: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES, INCLUDING THE TALUS BONE MODEL. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. 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. IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE PROBLEM REGARDING THE TALUS BONE MODEL AND, ADDITIONALLY, THE SURFACE MATCH BETWEEN THE PROPHECY TALUS GUIDE AND PATIENT¿S TALUS BONE. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS VS GUIDE FIT AND FEEL, OR USER ERROR DURING SURGERY. 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. 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 THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE TALAR BONE MODEL SUPPLIED WAS TOTALLY DIFFERENT FROM THE PATIENT'S SEATED ANATOMY AT THE NECK OF THE TALUS, AND IT WAS IMPOSSIBLE FOR ME TO POSITION THE TALAR PROPHECY PS. I WAS OBLIGED TO USE THE METALLIC ANCILLARY TO DO THE TALAR HORIZONTAL CUT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE TALAR BONE MODEL SUPPLIED WAS TOTALLY DIFFERENT FROM THE PATIENT'S SEATED ANATOMY AT THE NECK OF THE TALUS, AND IT WAS IMPOSSIBLE FOR ME TO POSITION THE TALAR PROPHECY PS. I WAS OBLIGED TO USE THE METALLIC ANCILLARY TO DO THE TALAR HORIZONTAL CUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207385 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1815523 00889797057141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown