Model Number 209063 |
Device Problems
Detachment of Device or Device Component (2907); Intermittent Loss of Power (4016)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
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
|
Bent tip blue probe.Mics won¿t pass registration.No surgical delay.Case type / application: tka.
|
|
Event Description
|
Bent tip blue probe.Mics won¿t pass registration.No surgical delay.Case type / application: tka.
|
|
Manufacturer Narrative
|
Reported event: an event regarding disassociation involving a mako mics was reported.The event was confirmed.Method & results: product evaluation and results: handpiece mics ¿ 209063 ¿ serial#(b)(6)- rma#(b)(4).Inspected per procedure and determined failure of the following test steps: 7.1.2 hand piece visual inspection.7.1.4 collar test.Original description confirmed.Disposition: rtv - loose screws - collar.Inspected by: (b)(4).Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the devices, including serial number (b)(6), were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 3 other similar events for the lot referenced.Conclusions: the alleged failure mode was confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|
|
Manufacturer Narrative
|
Upon further review it has been determined that this event is not reportable.The awareness date of this event is after this device was received and repaired by the manufacturer, which makes this event out of scope of recall z-0472-2021; therefore, this mdr is being cancelled.The event is covered under the total knee arthroplasty mako system risk table, hazardous situation ¿user is not provided adequate indication for registration confirmation¿ that the highest potential severity of harm is s1.
|
|
Event Description
|
Bent tip blue probe.Mics won¿t pass registration.No surgical delay.Case type / application: tka.
|
|
Search Alerts/Recalls
|