BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRA-CUT

    MDR report key: 13798170 · Received March 16, 2022

    Report

    Report Number
    MW5108210
    Event Type
    Injury
    Date Received
    March 16, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 14, 2022
    Manufacturer
    ACRA CUT, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DISPOSABLE CRANIAL PERFORATOR BROKE WHILE IN USE. PORTION THAT BROKE WAS THE CONNECTION INSIDE THE PERFORATOR ATTACHMENT OF STRYKER DRILL SET REMOVED FROM FIELD AND REPLACED. BOTH PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525836 ACRA-CUT DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) HBF ACRA CUT, INC. 210-221 10134

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention