BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM / 2.8MM THIN DRILL GUIDE

    MDR report key: 3818019 · Received April 29, 2014

    Report

    Report Number
    3025141-2014-00060
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING AND INSPECTION RECORDS SHOWED NO ISSUES AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS BATCH NUMBER. A VISUAL EXAMINATION WAS PERFORMED UNDER MAGNIFICATION. THERE IS NO VISUAL DAMAGE THAT WOULD AFFECT THE FUNCTION OF THE DRILL GUIDE. ADDITIONAL MDR ASSOCIATED WITH THIS EVENT: 3025141-2014-00059: P/N 80-0387 DRILL.

    Description of Event or Problem · 1

    FOLLOWING ORTHOPEDIC SURGERY, THE SURGEON WAS CHECKING THE X-RAY AFTER CLOSING THE SURGICAL SITE AND FOUND THAT A FRAGMENT OF ONE OF THE DRILLS USED DURING SURGERY WAS LEFT IN THE PT'S BODY. THE INCISION WAS REOPENED AND THE FRAGMENT WAS RETRIEVED. THE SURGICAL SITE WAS CLOSED WITH NO FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255510 2.0MM / 2.8MM THIN DRILL GUIDE SURGICAL DRILL GUIDE, PRODUCT CODE: HRS HRS ACUMED LLC 80-0387 309908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention