Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that an instrument fractured on an unknown date due to unknown reasons.There was no reported harm or injury to a patient.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device had fractured at the mid shaft weld location.There is a cable still holding the two sides of the fracture together.There are indentations on the shaft, strike plate, and the tip of the locking feature.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|