Model Number 209063 |
Device Problems
Failure to Cut (2587); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.Mics headpiece- serial number specific recall was initiated for the mics handpieces within scope of a capa.The investigation revealed that only specific the catalog number and serial numbers are impacted by the regulatory action.The root cause analysis identified a characterization issue associated with the mako integrated cutting system (mics) handpiece.Users have been instructed to return any specified hand piece to stryker.
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Event Description
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Mics power would not pass multiple angled saw attachments prior to bone resection.No surgical delay.Case type / application: tka.
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Event Description
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Mics power would not pass multiple angled saw attachments prior to bone resection.No surgical delay.Case type / application: tka.
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Manufacturer Narrative
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Reported event an event regarding non functional involving a mako mics was reported.The event was not confirmed during inspection.Method & results product evaluation and results: handpiece mics ¿ 209063 ¿ serial#(b)(6) - rma#(b)(4).Inspected per d06917 and was unable to determine the failure of any test steps.Original description not confirmed.Disposition: rtv inspected clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices, including serial number (b)(6), were manufactured and accepted into final stock 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 during inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Search Alerts/Recalls
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