Model Number 2544-01-014 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/11/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Nurses reported missing balseal from attune trial and spacer block.No surgical delay.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|