BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOFIX

    MDR report key: 370126 · Received December 21, 2001

    Report

    Report Number
    370126
    Event Type
    Injury
    Date Received
    December 21, 2001
    Date of Event
    November 8, 2001
    Report Date
    December 21, 2001
    Manufacturer
    ORTHOFIX
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCREWS PACKAGED IN SINGLE PEEL-PACK POUCH WERE DELIVERED INSIDE SCREW-TOP PLASTIC TUBE. OUTSIDE OF PLASTIC TUBE WAS MARKED "STERILE". BECAUSE THE CONTAINER WAS NOT TAMPER-RESISTANT AND BECAUSE THE SCREWS WERE IN A SINGLE (NOT DOUBLE) PEEL-PACK, THE OPERATING ROOM STAFF QUESTIONED THE PRODUCT PACKAGING AND STERILITY AT THE TIME OF SURGERY. THE CO REP, WHO WAS PRESENT IN OR, VERIFIED STERILITY AND THIS WAS ALSO CONFIRMED BY TELEPHONE WITH THE MFR DURING THE PROCEDURE. THE SCREWS WERE INSERTED FOLLOWING THESE VERIFICATIONS. THE PT DEVELOPED AN INFECTION AND REQUIRED (1) RETURN TO OR FOR REMOVAL OF FIXATION DEVICE AND APPLICATION OF LONG LEG CAST THE NEXT MONTH; (2) INSERTION OF CENTRAL LINE CATHETER TWO DAYS LATER FOR 6 WEEK COURSE OF ANTIBIOTIC TREATMENT. MAY ALSO REQUIRE ADD'L SURGERY FOR REINSERTION OF EXTERNAL FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58311 ORTHOFIX EXTERNAL FIXATOR SCREWS HWC ORTHOFIX * 10A01

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R