Model Number 2236-00-008 |
Device Problems
Dull, Blunt (2407); Failure to Cut (2587); Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 07/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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
|
It was reported that the 38 poly trials are damaged with scars and missing plastic in areas surgeon and spd wanted them replaced.Protective plate is bent and won¿t sit flush on the bone.The reamers are dulled and have burrs.These items were pulled out of the sets and not used in a case.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.The previous reported device code failure to cut is being corrected to more appropriate code which is dull or blunt.
|
|
Search Alerts/Recalls
|