BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER 56MM

    MDR report key: 3811124 · Received March 24, 2014

    Report

    Report Number
    9614497-2014-00049
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 24, 2014
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER THAT THE DEVICE WILL BE RETURNED TO (B)(4) 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 MARCH 17, 2014, CUSTOMER REPORTS: DURING AN UNKNOWN PROCEDURE ON A MEDIUM BUILD MALE PATIENT, THE PRODUCT HAD WEAR/FATIGUE. THERE WAS NO PATIENT IMPACT, INJURY OR ADVERSE EVENTS REPORTED. SURGERY WAS COMPLETED WITHOUT SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172773 ACETABULAR REAMER 56MM REAMER HWE GREATBATCH MEDICAL SA 00-7803-095-56 79836000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR