BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 9734600 · Received February 20, 2020

    Report

    Report Number
    3008480376-2020-00003
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 31, 2020
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Product Code
    JDS
    PMA / PMN Number
    K141737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOR THE SUBJECT H10 DRIVER MODEL, CONVENTUS ORTHOPAEDICS, INC. REVIEWED THE APPLICABLE DHRS (TRACEABILITY CONTROL FORMS) AND DHF (INCLUDING DESIGN CHANGE ORDERS). THE DHR REVIEW FOUND NO MANUFACTURING DEFICIENCIES. THE DHF REVIEW ESTABLISHED THAT THE DRIVER DESIGN HAD BEEN DIMENSIONALLY SCALED UP FROM AN EXISTING DRIVER MODEL USED FOR A DIFFERENT CONVENTUS IMPLANT SYSTEM, WITH INADEQUATE VERIFICATION AND VALIDATION CONDUCTED FOR THE NEW MODEL. ADDITIONALLY, A SERIES OF INADEQUATE DESIGN CHANGES LED TO UNANTICIPATED DIMENSIONAL TOLERANCE STACK-UP. OVERALL, IT HAS BEEN CONCLUDED THAT THE INADEQUATE DESIGN OF THE SUBJECT H10 DRIVER MODEL CAUSED THE EVENT. THIS DESIGN ISSUE IS BEING ADDRESSED THROUGH THE CAPA PROCESS.

    Additional Manufacturer Narrative · 1

    CONVENTUS ORTHOPAEDICS, INC. REVIEWED THE TRACEABILITY CONTROL FORMS FOR THE H10 DRIVER, THEN DETERMINED THAT THERE WERE NO PRODUCTION ISSUES THAT OCCURRED DURING PACKAGING, LABELING, OR RECEIVING OF THE PRODUCT. THE INVESTIGATION IS IN PROGRESS. FOLLOW-UP REPORT(S) WILL BE SUBMITTED UPON OBTAINING ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, DURING THE PH CAGE REMOVAL SURGERY, ONE H10 DRIVER BROKE OFF IN A SCREW (EITHER MODEL NO. 7768-1 OR 7036-1), KEEPING THE PLATE IN PLACE UNTIL IT WAS LIFTED OFF THE BONE. A SMALL OSTEOTOMY WAS ATTEMPTED TO EXPOSE THE CAGE SUPERIORLY. THE SURGEON THEN LOOSENED THE CAGE AND REMOVED IT FROM THE HUMERAL HEAD. CONVENTUS ORTHOPAEDICS, INC. IS SUBMITTING TWO SEPARATE MDRS FOR THIS EVENT BASED ON THE CURRENT INFORMATION. THIS MDR IS REGARDING THE 120 MM H10 SOLID DRIVER WITH THE MODEL NO. 7768-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199652 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC. 7768-1 10255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other