Model Number 2545-00-706 |
Device Problems
Material Discolored (1170); Illegible Information (4050)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 01/01/2020 |
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 color markings are wearing off (12 trials).
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.The noted damage is consistent with wear due to many cycle of use in the field.The investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
|
|
Search Alerts/Recalls
|