BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 19465980 · Received June 5, 2024

    Report

    Report Number
    9614209-2024-00335
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 8, 2024
    Report Date
    August 1, 2024
    Manufacturer
    CORIN LTD
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE TRINITY ACETABULAR SHELL THAT THE HANDLE GOT STUCK TO, CONFIRMATION ON WHETHER THE HANDLE EVENTUALLY DETACHED FROM THE SHELL OR WAS THE IMPACTED SHELL REMOVED AND ALTERNATIVE LOCATED AND USED AND CONFIRMATION ON THE QUANTITY OF AFFECTED DEVICES HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS FOR THE HANDLE HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. UPON RECEIPT OF THE PART NO. AND LOT CODE OF THE ASSOCIATED TRINITY ACETABULAR SHELL, THESE MANUFACTURING RECORDS WILL ALSO BE IDENTIFIED AND REVIEWED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT: ADDITIONAL INFORMATION INCLUDING THE PART NO. AND LOT CODE OF THE TRINITY ACETABULAR SHELL THAT THE HANDLE GOT STUCK TO, CONFIRMATION ON WHETHER THE HANDLE EVENTUALLY DETACHED FROM THE SHELL OR WAS THE IMPACTED SHELL REMOVED AND ALTERNATIVE LOCATED AND USED AND CONFIRMATION ON THE QUANTITY OF AFFECTED DEVICES WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, THIS INFORMATION WAS NOT PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE REPORTED DEVICES HAVE NOT BEEN RETURNED FOR EXAMINATION. THE APPROPRIATE DEVICE DETAILS FOR THE HANDLE WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD HAS BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THIS RECORD CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE AVAILABLE INFORMATION, NO FURTHER INVESTIGATION CAN BE CONDUCTED. THIS REPORT CANNOT BE CONFIRMED AND THE ROOT CAUSE CANNOT BE DETERMINED. THEREFORE, THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    DURING SURGERY THE TRINITY STD INTRODUCER / IMPACTOR HANDLE WOULD NOT RELEASE FROM THE ACETABULAR CUP. SURGERY WAS EXTENDED UNDER 30 MINUTES.

    Description of Event or Problem · 0

    DURING SURGERY THE TRINITY STD INTRODUCER / IMPACTOR HANDLE WOULD NOT RELEASE FROM THE ACETABULAR CUP. SURGERY WAS EXTENDED UNDER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295282 TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN LTD 921.129G 089804-17

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRINITY ACETABULAR SHELL: DEVICE DETAILS UNKNOWN.| TRINITY ACETABULAR SHELL: DEVICE DETAILS UNKNOWN.