|
Model Number 72413575 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during inspection, (3) evos 3.5mm x 75mm lck scr s-t were found to be incorrectly packaged, because the screws on the package were 70cm screws and not 75cm screws.There was no patient involved.
|
|
Manufacturer Narrative
|
H6, h7 and h9: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; this failure mode will be monitored for future complaints for any necessary corrective actions.However, internal investigation concluded that this event was previously identified and investigated.Based on the quality investigation, the root cause of the reported event was the failure to ensure shop order paperwork matches actual product during the manufacturing process.At this time, we have reason to suspect that the product failed to meet product specifications at the time of manufacture.As a result of the investigation, several process improvements were implemented related to training, process monitoring and in process inspection.In addition, containment and remedial actions were performed for the impacted finished product.Should additional information be received, the complaint will be reopened.We will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Remedial action is associated with internal reference # r-2021-09.
|
|
Search Alerts/Recalls
|
|
|