Catalog Number 09-0252 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that three elevators were broken during a procedure.The doctor was able to retrieve the broken pieces.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).Exodontia elevr #46r serrated cat#09-0252 lot#ni.Exodontia elevr #46r serrated cat#09-0252 lot#ni.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2023 - 00231.0001032347 - 2023 - 00232.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.H3: other - device not returned and insufficient information provided.No product was returned and no pictures were provided.Medical records were not provided.As the lot number is unknown, the dhr could not be reviewed.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|