Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the tip of the instrument fractured.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information. reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|