Catalog Number LONG-HD |
Device Problems
Break (1069); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/27/2018 |
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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We finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.
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Manufacturer Narrative
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Reported event: we finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.Product evaluation and results: visual inspection (see attachments) the collar and shaft of the attachment became separated.No observation of damage or handling issues with the attachment.Dimensional inspection not performed as the anspach hd long attachment is an oem product.Material analysis not performed as this device is an oem product.Functional inspection not performed as the failure mode of the separated attachment was confirmed through visual inspection.Product history review: not performed as the device is an oem product complaint history review: a review of complaints in trackwise related to p/n 110920 or long-hd, s/n (b)(4), shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode of separated device making the device unusable is confirmed.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.
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Event Description
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We finished burring the femur and had just started to burr the tibia when the anspach started to back out of the end effector.We ended up taking the anspach completely out and realized that the hd long was broken.This was after a good rio registration and burr check.Case type: pka.
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Search Alerts/Recalls
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