BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES

    MDR report key: 17969994 · Received October 19, 2023

    Report

    Report Number
    3010667733-2023-00615
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 8, 2023
    Report Date
    December 19, 2023
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    HSN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. 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. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT 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 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. ¿ THE STANDARD IDENTIFIER FOR THE PACKAGING AND THE GUIDES ARE THE CASE NUMBER AND SURGEON¿S LAST NAME PATIENT INITIALS OR ANOTHER PATIENT IDENTIFIER IS NOT INCLUDED. NO ROOT CAUSE IDENTIFIED: ¿ NO ERROR IN THE INTERNAL PROCESS WAS FOUND REGARDING THE GUIDE LABELING AND OTHER CASE IDENTIFIERS IN THE PACKAGING. 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

    IT WAS REPORTED THAT THE PATIENT ID ON THE PROPHECY GUIDE COULD NOT BE IDENTIFIED. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ID ON THE PROPHECY GUIDE COULD NOT BE IDENTIFIED. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750702 PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN WRIGHT MEDICAL TECHNOLOGY INC 1766997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown