Catalog Number ZZINAUN0020 |
Device Problem
Defective Device (2588)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/15/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
(b)(6) hospital (b)(6) 2018 - kick navigation system.This case was interesting as we set the tibial cut to 8mm.After cutting we manual measured the tibial bone cut with our calipers and it came up as a 10mm cut.Then when verifying the cut using the four ball array the computer said we have undercut by -2mm making it a 6mm cut.As you can see by the report (refer to the source data) we used a 10mm poly so the numbers don¿t match up.Female patient (b)(6).This will be investigated by (b)(4) - johnson & johnson medical, (b)(4).A report will be provided to depuy international upon completion of the investigation.
|
|
Manufacturer Narrative
|
This product was reported in error.Depuy doesn¿t have the responsibility to make a reporting determination and submit adverse event reports for this instrument.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
|
|
Manufacturer Narrative
|
Pc(b)(4).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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|