BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 20501837 · Received October 22, 2024

    Report

    Report Number
    3010667733-2024-00770
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 23, 2024
    Report Date
    December 26, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    UDI-DI
    00889797057141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULDN'T BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. PROPHECY TEAM REVIEWED THE RECEIVED INFORMATION AND NOTED: CONCLUSIONS: THE CT SCAN WAS PROCESSED WITHIN NORMAL, ACCEPTABLE RANGES. NO ERRORS WERE IDENTIFIED DURING THE SEGMENTATION PROCEDURE. THE ALIGNMENT, SIZING AND GUIDES WERE PERFORMED AND 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. FROM THE PROPHECY OPERATIONS PERSPECTIVE, ALL PROCEDURES WERE FOLLOWED UP ACCORDINGLY AND THE IMPLANT SIZING WAS CHOSEN BASED UPON THE PATIENT¿S ANATOMY CLUES AS USUAL. NO ERRORS WERE IDENTIFIED THAT SUGGEST AN INCORRECT SELECTION OF SIZES WAS PERFORMED. ROOT CAUSE IDENTIFIED: IT WAS NOT POSSIBLE TO IDENTIFY WHAT CAUSED THE INTRAOPERATIVE SIZING ISSUE MENTIONED IN THE COMPLAINT¿S EMAIL. A POTENTIAL ROOT CAUSE MAY BE A DISCREPANCY IN USER EXPECTATIONS REGARDING THE SIZING PROVIDED IN THE REPORT VS THE SIZING EVALUATION PERFORMED DURING SURGERY. 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. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED BY STRYKER COMMERCIAL REPRESENTATIVE REGARDING PROPHECY (B)(4): AFTER HAVING A HAD A COMPLAINT CASE IN MY LAST PROPHECY INFINITY (PI 3745949) TODAY WE HAD AN ISSUE AGAIN. THE PLANNING OF THE CURRENT CASE WAS A TIBIA SIZE 1 AND A TALUS SIZE 2. DURING THE OPERATION WE FOUND THAT THESE SIZES ARE NOT A GOOD FIT (TOO SMALL, LEFT) AND DECIDED TO MOVE UP TO A SZ 3, TIBIA AND A TALUS SZ 2.

    Description of Event or Problem · 0

    AS REPORTED BY STRYKER COMMERCIAL REPRESENTATIVE REGARDING PROPHECY CASE100467: AFTER HAVING A HAD A COMPLAINT CASE IN MY LAST PROPHECY INFINITY (TODAY WE HAD AN ISSUE AGAIN. THE PLANNING OF THE CURRENT CASE WAS A TIBIA SIZE 1 AND A TALUS SIZE 2. DURING THE OPERATION WE FOUND THAT THESE SIZES ARE NOT A GOOD FIT (TOO SMALL, LEFT) AND DECIDED TO MOVE UP TO A SZ 3, TIBIA AND A TALUS SZ 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324872 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1794972 00889797057141

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown