Catalog Number 110024773 |
Device Problems
Difficult or Delayed Activation (2577); Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).G2: foreign- denmark.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.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
|
It was reported that the juggerstitch device did not release the implant properly and the black trigger was very resistant.Another device was used to complete the procedure.No adverse event has been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.
|
|
Event Description
|
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The reported event has been made not reportable.
|
|
Search Alerts/Recalls
|