MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 111140 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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While performing partial knee right medial arthroplasty, slap hammer was broken during femur trial impaction.
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Manufacturer Narrative
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Product not available to stryker; reason for no evaluation and reason code.An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was not confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.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 have been 02 other events for the lot referenced.The event could not be confirmed nor could the root cause be determined because the devices were not returned for evaluation and insufficient information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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While performing partial knee right medial arthroplasty, slap hammer was broken during femur trial impaction.
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Search Alerts/Recalls
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