Catalog Number 212760 |
Device Problem
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 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the 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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Screw fell out of offset reamer in spd.Found screw and is with reamer.Screw is not in patient.Case type / application: tha 4.1.
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Manufacturer Narrative
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An event regarding disassociation involving a mako reamer handle was reported.The event was confirmed method & results: product evaluation and results: functional inspection confirms the offset reamer screw is loose.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been other complaints with similar event(s) 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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Event Description
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Screw fell out of offset reamer in spd.Found screw and is with reamer.Screw is not in patient.Case type / application: tha 4.1.
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Search Alerts/Recalls
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