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 12/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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T handle broke off in trial when pulling trial out of patient.
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Event Description
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T handle broke off in trial when pulling trial out of patient.
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Manufacturer Narrative
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An event regarding crack/fracture involving a femoral trial slap hammer 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 has been 1 other similar reported complaint.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been 01 other similar events for the reported lot.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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Search Alerts/Recalls
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