BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 12369307 · Received August 26, 2021

    Report

    Report Number
    9614209-2021-00103
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 19, 2021
    Report Date
    January 14, 2022
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER -4069 FINAL REPORT ADDITIONAL INFORMATION, INCLUDING THE ANGULATION OF WHICH THE SCREW WAS INSERTED, POST OP X-RAYS, OPERATIVE NOTES, DETAILS OF THE INSTRUMENTS USED FOR SCREW HOLE PREPERATION, WHETHER THE CUP WAS FULLY IMPACTED PRIOR TO INSERTION OF THE SCREW, HOW MANY SCREWS WERE IMPLANTED IN TOTAL, WHETHER THE SURGEON WAS SATISFIED WITH THE CUP FIXATION AND A PHOTOGRAPH OF THE BROKEN SCREW WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, HOWEVER, NOT ALL INFORMATION WAS PROVIDED AND THUS THE SCOPE OF THE INVESTIGATION WAS LIMITED. THE SCREW WAS DISCARDED OF AND THUS COULD NOT BE EXAMINED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THIS RECORD CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. CORIN HAS NOT RECEIVED ANY OTHER REPORTS RELATING TO DEVICES FROM THIS BATCH. NO FURTHER INVESTIGATION CAN BE CONDUCTED WITH THE AVAILABLE INFORMATION AND THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THIS IS THE ONLY REPORT THAT CORIN HAS RECEIVED FOR THIS FAILURE AND THUS IS CONSIDERED AS AN ISOLATED EVENT. THIS CASE IS NOW CONSIDERED CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. 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 SCREW STRIPPED AS IT WAS BEING IMPLANTED, THIS MEANT IT COULD NOT BE IMPLANTED ANY FURTHER INTO THE BONE AND THUS AN ALTERNATIVE SCREW WAS LOCATED AND IMPLANTED WITH NO ISSUES. THE AFFECTED SCREW DISCARDED OF AND THERE WAS NO IMPACT TO THE PATIENT. SURGERY WAS EXTENDED BY APPROXIMATELY 20 MINUTES.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION, INCLUDING THE ANGULATION OF WHICH THE SCREW WAS INSERTED, POST OP X-RAYS, OPERATIVE NOTES, DETAILS OF THE INSTRUMENTS USED FOR SCREW HOLE PREPARATION, WHETHER THE CUP WAS FULLY IMPACTED PRIOR TO INSERTION OF THE SCREW, HOW MANY SCREWS WERE IMPLANTED IN TOTAL, WHETHER THE SURGEON WAS SATISFIED WITH THE CUP FIXATION AND A PHOTOGRAPH OF THE BROKEN SCREW 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 HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. 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 · 1

    DURING SURGERY PART OF THE TRINITY SCREW STRIPPED OFF AS IT WAS BEING IMPLANTED. THE PIECE OF THE SCREW WHICH STRIPPED OFF, AND DEVICE ITSELF WERE DISCARDED OF AND THERE WAS NO IMPACT TO THE PATIENT. SURGERY WAS EXTENDED BY APPROXIAMATELY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272695 TRINITY CANCELLOUS BONE SCREW LWJ CORIN MEDICAL 321.040 452317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown