MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 111140 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Item broken.Screw end stuck into item 170513.
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Manufacturer Narrative
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An event regarding crack/fracture involving a femoral trial slaphammer was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there have been no other similar reported events.Conclusions: the reported event cannot be confirmed, or the root cause determined as the instrument was not returned for evaluation.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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Item broken.Screw end stuck into item: 170513.
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Search Alerts/Recalls
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