Events

Field Safety Notices about Offset Reamer Handle

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Greatbatch Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    On june 14, 2016 greatbatch medical identified an issue with the 00-7804-080-00 offset reamer handle, as field complaints were reported that the drive chain mechanism seizes during use. the function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during a total hip arthroplasty. during seizing, the device is rendered non- functional in the operating room. the risks associated with this failure are: 1. the offset reamer handle seizes and the surgery must be completed with an alternate device, leading to a delay of 30 minutes or greater from the scheduled surgery time. 2. the offset reamer handle seizes and no replacement device is available in the hospital, leading to an interruption and rescheduling of surgery. .

Device

Offset Reamer Handle

Manufacturer

Greatbatch Medical