BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP

    MDR report key: 2801484 · Received October 11, 2012

    Report

    Report Number
    2648666-2012-00332
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IRRIGATION OF THE SURGICAL WOUND AT THE L5-S1 SPINE LEVEL, THE UNIT CLOGGED WITH BONE PIECES. THE STAFF TOOK THE GUARD OFF TO UNCLOG IT. THEY HEARD A KNOCKING SOUND AS THEY STARTED TO USE IT. THEY BELIEVE THE GUARD CRACKED WHEN THEY TRIED TO PUT IT BACK ON. THEY USED THE HANDPIECE AND THE GUARD CAME OFF, GOING PAST THE WOUND TEARING THE DURA. THE GUARD DID NOT FALL INTO THE WOUND SITE. THE DOCTOR USED A MESH COVERING AND SUTURES TO REPAIR THE TEAR. THE PT WAS ALREADY GOING TO BE ON ANTIBIOTICS REGARDLESS IF THE TEAR OCCURRED. THE PT IS CURRENTLY IN GOOD CONDITION. THE PT DID NOT REQUIRE ADDITIONAL ANESTHESIA. IT IS UNK IF THERE WAS A DELAY OR IF A BACK-UP DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP FQH STRYKER INSTRUMENTS PUERTO RICO 12215012

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R