Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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
|
It was reported that the instrument was found to be chipped by a member of the sterile processing department.All available information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.H6 : tasp bottom- mechanical (g04) - provisional bottom.Visual examination of the returned product found it to exhibit signs of repeated use and is fractured complaint was confirmed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
|