BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 9826452 · Received March 12, 2020

    Report

    Report Number
    3008480376-2020-00012
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    March 3, 2020
    Report Date
    March 31, 2020
    Manufacturer
    CONVENTUS ORTHOPAEDICS, INC.
    Product Code
    JDS
    PMA / PMN Number
    K141737
    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

    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, THE SURGEON IMPLANTED A PH CAGE. DURING THE SURGERY, THE TIPS OF TWO H10 SOLID DRIVERS BROKE OFF INTO SCREW HEAD(S). REMOVAL WAS NOT DEEMED NECESSARY AS THE TIPS WERE FLUSH WITH THE SCREW HEAD(S). CONVENTUS ORTHOPAEDICS, INC. IS SUBMITTING TWO SEPARATE MDRS FOR EACH OF THESE TWO BREAKAGE EVENTS. THIS MDR IS REGARDING THE H10 DRIVER (MODEL NO. 7768-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291081 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC. 7768-1 10255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other