Model Number 212186 |
Device Problem
Residue After Decontamination (2325)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
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.Device not returned.
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Event Description
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Oil seems to be leaking from the back/broken o-ring.Case type / application: tka.
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Manufacturer Narrative
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Reported event an event regarding foreign matter involving a mako saw attachment was reported.The event was not confirmed.Method & results product evaluation and results: functional inspection does not confirm presence of foreign matter.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.Complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusions: preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode was not 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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Oil seems to be leaking from the back/broken o-ring.Case type / application: tka.
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Search Alerts/Recalls
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