BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHAMFER CUTTER SIZE 50

    MDR report key: 4308683 · Received November 25, 2014

    Report

    Report Number
    9614497-2014-00240
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER, 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. COMPLAINT INFO PROVIDED BY SMITH AND NEPHEW. (B)(4).

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION SO THE REPORTED EVENT CANNOT BE CONFIRMED. NO FURTHER INVESTIGATION REQUIRED.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    DURING AN UNK PROCEDURE THE CHAMFER REAMER TOOK A SMALL RING OF EXTRA BONE (1-2MM) FROM THE PT. THERE WERE NO REPORTED ADVERSE EVENTS OR PT INJURY RESULTING FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766400 CHAMFER CUTTER SIZE 50 REAMER HTO GREATBATCH MEDICAL SA 90127607 80250070001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other