Catalog Number 212480 |
Device Problems
Mechanical Problem (1384); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.
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Manufacturer Narrative
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Reported event: upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized device evaluation and results: not performed as the product was not returned for evaluation.The described failure mode could be caused by fracture of the locking mechanism components device history review a review of the device history records shows that on 12/6/16 28 parts were inspected, and accepted with no failures reported.Complaint history review a review of complaints in catsweb and trackwise related to p/n 212480, lot number 3500394 shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If additional information that would change this investigation becomes available, this investigation will be reopened.The issue occurred during a case and resulted in a 30 minute delay.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.The device was not returned for evaluation.
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Event Description
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Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.
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Manufacturer Narrative
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Follow-up #2 and final report submitted to update sections g4, g.5.
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Event Description
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Upon switching sawblade attachments during total knee procedure, the angled sawblade attachment would not tighten to hold the sawblade in place.There was a 30 minute delay while we waited for previously used attachment to be cleaned and sterilized.
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Search Alerts/Recalls
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