MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 160177 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
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Event Description
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Blue impactor on the end of the tibial impactor broke.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed because no medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies there has been no other event for the lot referenced.The event could not be confirmed nor the root cause determined because the device was not returned for evaluation and insufficient information was provided.If the device and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Blue impactor on the end of the tibial impactor broke.
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Search Alerts/Recalls
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