BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT CONE SPLASH SHIELD

    MDR report key: 1812707 · Received August 11, 2010

    Report

    Report Number
    2648666-2010-00350
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    November 19, 2009
    Report Date
    August 9, 2010
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    K972069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FRAGMENT IS BEING HELD AT THE ACCOUNT. THE LOT NUMBER SUPPLIED BY THE ACCOUNT FOR THE DEVICE DOES NOT MATCH THE LOT NUMBERING SCHEME USED BY THE MFR. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED IF ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWENTY THREE DAYS AFTER BEING DISCHARGED FROM A HEMIARTHROPLASTY DUE TO FEMORAL NECK FRACTURE, THE PT RETURNED TO THE FACILITY DUE TO DRAINAGE. THE WOUND SITE WAS IRRIGATED AND DEBRIDED. AT THIS TIME, THE TIP OF THE DEVICE FELL OFF AND ENTERED THE SITE WITHOUT THE KNOWLEDGE OF THE SURGEON. THREE MONTHS AFTER THIS IRRIGATION DUE TO DRAINAGE, THE PT EXHIBITED DRAINAGE AGAIN. THIS WAS WHEN THE UNRETRIEVED DEVICE FRAGMENT WAS DISCOVERED. THE HIP IMPLANT WAS EXPLANTED AND ANTIBIOTIC BEADS WERE INTRODUCED INTO THE SURGICAL SITE. THE HIP IMPLANT HAS NOT BEEN RE-IMPLANTED AT THIS TIME AND IT IS UNK WHEN THE PROCEDURE WILL BE RESCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT CONE SPLASH SHIELD JET LAVAGE FQH STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention