Model Number N/A |
Device Problems
Crack (1135); Fracture (1260)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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 the instrument was found cracked upon receipt.The crack was found at the flat wider portion of the instrument.There was no patient involvement.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).Health effect - clinical code.From 2645 - no patient involvement to 4582 - no clinical signs, symptoms or conditions.Device code(s).From 1135 ¿ crack to 1260 ¿ fracture.This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|