Model Number 209063 |
Device Problems
Difficult or Delayed Positioning (1157); Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/14/2021 |
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.
|
|
Event Description
|
Handle of mics was shaking more than normal and difficult to keep still during reaming of acetabulum without twisting surgeon's wrist.No surgical delay.Case type / application: tha.
|
|
Manufacturer Narrative
|
Reported event an event regarding electrical failure and non functional involving a mako mics was reported.The event was not confirmed.Method & results product evaluation and results: wo-04387926.Problem reproduced? no (original failure not confirmed) work performed part# 209063.Rma# 318280.Sn# (b)(6).Replaced part# 214466 (additional failure - cable replaced) depot service technician: (b)(6).Successfully performed inspection per d06917.Successfully performed mics repair per do6895.Tested per qip 0243 test pass screen shot attached.All parts listed in consumables.Mics can be returned to stock.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate that devices including serial number (b)(6), were manufactured and accepted into final stock on 10/29/2020 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.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
|
Handle of mics was shaking more than normal and difficult to keep still during reaming of acetabulum without twisting surgeon's wrist.No surgical delay.Case type / application: tha.
|
|
Search Alerts/Recalls
|