Catalog Number 212760 |
Device Problems
Contamination (1120); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/08/2018 |
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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Biofilm build up discovered inside the offset reamers and in line offset impactors.Tha procedure delayed more than 5 minutes.
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Manufacturer Narrative
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Reported event: the event reported that 4 offset reamer handles and 4 trident inline-offset impactors had biofilm build up.The procedure was delayed 5 minutes.Device evaluation and results: visual inspection showed no foreign matter (biofilm) or debris.The yokes of the proximal u-joint was found to be worn at the edges.Functional inspection showed that the device rotated freely and smoothly.Device history review: review of device history records indicate 7 parts were dispositioned "use as is" on (b)(6)2017 per qt 17-05-0089.The non-conformance was not related to the failure in this complaint.Fifteen (15) of 23 parts were dispositioned "use as is" on (b)(6) 2017 per qt 17-05-0016.The non conformance was unrelated to the failure in this investigation.Eight (8) of the 23 parts were dispositioned to remain in np for further disposition per qt 17-05-0016 on (b)(6) 2017.The nonconformance's were unrelated to the failure in this complaint.Complaint history review: review of complaints for p/n 212760, l/n 3578991 show no other complaint related to the failure in this complaint.Conclusion: the failure was not confirmed.Biofilm was not seen within the device.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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Biofilm build up discovered inside the offset reamers and in line offset impactors.Tha procedure delayed more than 5 minutes.
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Search Alerts/Recalls
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