Model Number 2012-06-300 |
Device Problems
Break (1069); Material Discolored (1170)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/07/2020 |
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
|
Trilock broach pan have faded and have started to chip after being in rotation for approx.10 years and thousands of case reprocessings.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary :the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|