Model Number 212480 |
Device Problem
Noise, Audible (3273)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/04/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of the 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
|
Saw attachment did not sound or perform properly during cuts.Case type: tka.Surgical delay: yes > 30 minutes.
|
|
Manufacturer Narrative
|
Reported event: saw attachment did not sound or perform properly during cuts.Case type: tka surgical delay: yes > 30 minutes product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa 2127499 has been raised for the same.Product history review: review of the device history records indicate 16 devices were manufactured and accepted into final stock on 11/01/2018 with no reported discrepancies.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212480, lot 35011018 shows 0 additional complaints related to the failure in this investigatio n.Conclusions : the failure could not be determined as 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.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
|
|
Event Description
|
Saw attachment did not sound or perform properly during cuts.Case type: tka.Surgical delay: yes > 30 minutes.
|
|
Search Alerts/Recalls
|