Model Number 219999 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Slipped (1584); Positioning Problem (3009)
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Patient Problem
Muscle/Tendon Damage (4532)
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Event Date 04/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed because the log/session files were not made available for review.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.-clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob1079 was inspected on (b)(6) 2020 and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 219999, robot number: rob1079 shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.
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Event Description
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Immediately after completing bone preparation, and posterior bone fragments were removed it was observed that the popliteal tendon was nicked and bleeding.Bleeding was able to be isolated and sutured with minimal delay in the case.Surgeon was requesting further information about if there have been other reported incidents of similar occurrences to help establish which cut he may have caused the nick on.
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Search Alerts/Recalls
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