Catalog Number 209830 |
Device Problem
Contamination (1120)
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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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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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Follow-up #1 and final report submitted to update sections based on the results of investigation.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 irregularities or damage.No foreign matter (biofilm) or debris was seen.Functional inspection showed that the device rotated freely and smoothly.It also inserted into a hip end effector with no issue.Review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 11/01/2016.No non-conformances were identified during inspection.Review of complaints within the trackwise database for p/n 209830, l/n 33850 show no other complaints related to the failure in this investigation.The failure was not confirmed.Biofilm was not seen within the device.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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Search Alerts/Recalls
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