Model Number 212480 |
Device Problems
Device Slipped (1584); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
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.
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Event Description
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During bone prep the doctor said that the screen was showing him cutting more medially than he actually was for the distal, posterior chamfer and posterior cuts.We ruled out any bumped bone arrays, checkpoints and base array/registration errors.No surgical delay.Case type / application: tka.
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Event Description
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During bone prep the doctor said that the screen was showing him cutting more medially than he actually was for the distal, posterior chamfer and posterior cuts.We ruled out any bumped bone arrays, checkpoints and base array/registration errors.No surgical delay.Case type / application: tka.
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Manufacturer Narrative
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Reported event: an event regarding locking mechanism failure involving a mako saw attachment was reported.The event was confirmed.Method & results: product evaluation and results: functional verification confirmed the event, the racheting mechanism was broken and would not hold the saw properly to make the cuts.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 on with no relevant reported discrepancies.Complaint history review: there have been 2 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.
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Search Alerts/Recalls
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