Catalog Number 14-440042 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Related events: 0001825034-2021-03006, 0001825034-2021-03007.
|
|
Event Description
|
It was reported that during an initial procedure, the jig was mal-aligned, not allowing the screws to go into nail correctly.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
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.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 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
|