Model Number 212186 |
Device Problem
Residue After Decontamination (2325)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/12/2022 |
Event Type
malfunction
|
Event Description
|
Probe will not pass probe check.Cutting attachment has brown rust residue coming out from inside the piece.No surgical delay.Case type / application: tka.
|
|
Manufacturer Narrative
|
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
|
|
Event Description
|
Probe will not pass probe check.Cutting attachment has brown rust residue coming out from inside the piece.No surgical delay.Case type / application: tka.
|
|
Manufacturer Narrative
|
Reported event an event regarding foreign matter involving a mako saw attachment was reported.The event was not confirmed because the product was not available for inspection.Method & results product evaluation and results: the product was not evaluated as the product was unavailable for inspection.If additional information is received, then the complaint will be reopened.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there are no other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|
|
Search Alerts/Recalls
|