Catalog Number 170705-2 |
Device Problems
Difficult to Remove (1528); Device Operates Differently Than Expected (2913)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/26/2016 |
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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Surgeon was trialing during a mako pka and the size 5x9mm trial got stuck in the patient/tibial baseplate.As a result excessive force had to be used to remove the trial and in the process the trial was severely damaged.Update per email received on (b)(6) 2016: there was a 15 minute surgical delay.
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Manufacturer Narrative
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Product available to stryker.An event regarding damage involving a tibial insert onlay trial was reported.The event was not confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were provided.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 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 additional information and/or device becomes available, this investigation will be reopened.
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Event Description
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Surgeon was trialing during a mako pka and the size 5x9mm trial got stuck in the patient/tibial baseplate.As a result excessive force had to be used to remove the trial and in the process the trial was severely damaged update per email received on (b)(6) 2016: there was a 15 minute surgical delay.
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Search Alerts/Recalls
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