BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 9826321 · Received March 12, 2020

    Report

    Report Number
    3008480376-2020-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    June 12, 2019
    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. CONVENTUS ORTHOPAEDICS, INC. ATTEMPTED TO SUBMIT THIS MDR ON FEBRUARY 26, 2020 AT 4:12PM. HOWEVER, A NEW WEBTRADER ACCOUNT NEEDED TO BE CREATED AND WAS NOT APPROVED UNTIL MARCH 11, 2020. AS SUCH, THIS MDR IS BEING SUBMITTED LATE.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF AN INTERNAL REVIEW OF PAST COMPLAINTS AND SERVICE RECORDS. ON (B)(6) 2019, THE SURGEON REMOVED A PH CAGE SYSTEM (PH CAGE, PLATE, AND SCREWS). DURING THE SURGERY, THE TIP OF TWO 120MM H10 DRIVERS BROKE OFF INTO THE HEADS OF THE SCREWS. THE SURGEON PROCEEDED WITH THE COMPLETE REMOVAL OF THE PH CAGE SYSTEM. CONVENTUS ORTHOPAEDICS, INC. IS SUBMITTING TWO SEPARATE MDRS FOR EACH OF THESE TWO BREAKAGE EVENTS. THIS MDR IS REGARDING THE FIRST OF THE TWO 120MM H10 DRIVERS (MODEL NO. 7768-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291059 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC. 7768-1 10255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other