BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ CLEAN REAMER HANDLE

    MDR report key: 3697742 · Received March 6, 2014

    Report

    Report Number
    9614497-2014-00001
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    January 24, 2014
    Report Date
    February 27, 2014
    Manufacturer
    GREATBATCH MEDICAL INC.
    Product Code
    HWE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN ROUTE. IT HAS BEEN COMMUNICATED BY ZIMMER, THAT THE DEVICE WILL BE RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. ONCE GREATBATCH MEDICAL RECEIVES THE DEVICE AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER EMAIL RECEIVED (B)(6) 2014 CUSTOMER REPORTS; DURING AN ANTERIOR TOTAL HIP PROCEDURE ON A PATIENT (UNKNOWN AGE AND GENDER), THE SURGEON WAS REAMING THE ACETABULUM AND THE HANDLE SNAPPED AT THE JUNCTION WHERE IT CONNECTS WITH THE POWER UNIT. THE SURGEON WAS CONTAMINATED AS THE REAMER HANDLE BROKE. USER HARM WAS REPORTED. DOCUMENTATION DOESN'T INDICATE PATIENT WAS INJURED AS A RESULT OF THE INCIDENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137965 EZ CLEAN REAMER HANDLE STRAIGHT REAMER HANDLE HWE GREATBATCH MEDICAL INC. 00-1206-090-10 56455910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other