Model Number 212760 |
Device Problems
Component Missing (2306); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
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 if additional information becomes available.
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Event Description
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A screw came out of the offset reamer handle.Case type / application: tha 4.0.
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Event Description
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A screw came out of the offset reamer handle case type / application: tha 4.0.
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Manufacturer Narrative
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Reported event an event regarding mechanical failure involving a mako reamer handle was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection confirmed the reported event.The reamer handle, offset is missing a screw.-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 confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Manufacturer Narrative
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Reported event: an event regarding mechanical failure involving a mako reamer handle was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection confirmed the reported event.The reamer handle, offset is missing a screw.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 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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A screw came out of the offset reamer handle.Case type / application: tha 4.0.
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Search Alerts/Recalls
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