Model Number 212760 |
Device Problems
Component Missing (2306); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
Event Type
malfunction
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Event Description
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Offset reamer handle had a few screws pop loose.Case type / application: tha 4.0.
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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 if additional information becomes available.
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Event Description
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Offset reamer handle had a few screws pop loose.Case type / application: tha 4.0.
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Manufacturer Narrative
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Reported event.An event regarding missing component involving a mako reamer handle was reported.The event was confirmed.Method & results.-product evaluation and results: visual inspection confirmed the reported event.Missing screw confirmed on handle near shaft.-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 were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there are no other complaints with a similar failure mode for this lot.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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