Catalog Number 111430 |
Device Problems
Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/25/2017 |
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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The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# (b)(4) broke off pin clamp part# (b)(4) prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.
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Manufacturer Narrative
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Reported event: the reported device is a dual pin base clamp assembly, catalog # 111430, lot #19220411 which broke during a case allowing the tibial array to become separated from the bone pin clamp.Device evaluation and results: visual inspection: visual inspection shows that the end of the clamp which should have the female thread for mounting the array clamp has broken off.Dimensional inspection: dimensional inspection was not completed as the visual inspection is sufficient to confirm the failure mode.Functional inspection: without the threaded end of the clamp; the array clamps cannot be secured to the bone pins.Device history review: a review of the device history record shows that (b)(4) parts were manufactured and accepted into stock on 10/4/11.Complaint history review: based on the device identification the complaint databases were reviewed from 2011 to present for similar reported events regarding a broken dual pin base clamp assembly.There has been no other event for the lot number referenced, however, there are 3 events for the part: (b)(4).Conclusions: the report of a broken 111430 bone pin clamp was not confirmed.The cause of the failure cannot be determined as the component which broke was not returned.The failure occurred during a case and caused a delay, however, the case was successful.Corrective action/preventive action: no further action is required.
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Event Description
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The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# 112100 broke off pin clamp part# 111430 prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.
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Manufacturer Narrative
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Follow up# 2 is being submitted to correct the catalog number and the lot number.The discrepancy was found on 10/25/2017.
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Event Description
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The surgeon was performing a partial knee arthroplasty procedure using the robotic arm interactive orthopedic system (rio) when the mako array clamp part# 112100 broke off pin clamp part# 111430 prior to incision.A second set was opened and that pin clamp assembly was utilized.Case proceeded without incident.
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Search Alerts/Recalls
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