Model Number 209063 |
Device Problems
Application Program Problem: Parameter Calculation Error (1449); Failure to Calibrate (2440)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/22/2022 |
Event Type
malfunction
|
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.Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.The capa investigation is currently in progress and an updated communication will be submitted upon completion of the investigation.
|
|
Event Description
|
Straight attachment passes, angled attachment shows constant ~2.9 value on multiple cutting attachments.Case type / application: tka.
|
|
Manufacturer Narrative
|
Reported event.An event regarding registration fails involving a mako mics was reported.The event was not confirmed.Method & results.Product evaluation and results: inspected and unable to determine original complaint.Original description not confirmed.Disposition: rtv.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 other complaints with a similar failure mode for this lot.Conclusions: the alleged failure mode was not confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|
|
Event Description
|
Straight attachment passes, angled attachment shows constant ~2.9 value on multiple cutting attachments case type / application: tka.
|
|
Search Alerts/Recalls
|