Model Number 212760 |
Device Problems
Detachment of Device or Device Component (2907); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the 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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Lock tight screw fell out of reamer handle and into the patients wound.Case type: tha.Surgical delay: = 15 minutes.
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Manufacturer Narrative
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It was reported that lock tight screw fell out of reamer handle and into the patients wound.Case type: tha.Surgical delay: = 15 minutes.Product evaluation and results: pr could not be completed as the 212760 offset cup reamer handle was not provided.Three communication attempts were made and appropriate information was not received.Product was not returned.Product history review: review of the device history records indicate 30 devices were manufactured and 0 were accepted into final stock on 04/22/2019.Certificate of conformity is available dated 03/27/2019.Review of qt 19-04-0087 revealed that the non conformance is not related to the failure alleged in the complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 212760, lot number 4642241 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Event Description
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Lock tight screw fell out of reamer handle and into the patients wound.Case type: tha.Surgical delay: = 15 minutes.
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Search Alerts/Recalls
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