BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVENTUS PHS SYSTEM

    MDR report key: 9722900 · Received February 18, 2020

    Report

    Report Number
    3008480376-2020-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 18, 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 · 1

    CONVENTUS ORTHOPAEDICS, INC. REVIEWED THE TRACEABILITY CONTROL FORMS FOR THE H10 SOLID DRIVER AND 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 OBTAINMENT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE SURGEON IMPLANTED A PH CAGE IN THE PATIENT. WHEN TIGHTENING THE FINAL 32 MM LOCKING SCREW BY HAND, THE TIP OF THE H10 DRIVER BROKE OFF IN THE HEAD OF THE 32 MM SCREW. THE SURGEON ATTEMPTED TO REMOVE THE TIP OF THE H10 DRIVER FOR 10 MINUTES BEFORE DECIDING TO LEAVE THE 32 MM LOCKING SCREW AND H10 DRIVER TIP. THE SURGEON PROCEEDED WITH THE SURGERY AND BEGAN CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187662 CONVENTUS PHS SYSTEM NAIL, FIXATION, BONE JDS CONVENTUS ORTHOPAEDICS, INC. 7768-1 9489

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other