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Catalog Number 212760 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2019 |
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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During reaming, a screw from the offset reamer shaft, came loose and fell into the wound.Case type: tha.
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Event Description
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During reaming, a screw from the offset reamer shaft, came loose and fell into the wound.Case type: tha.
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Manufacturer Narrative
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The reported device was a offset cup reamer handle, p/n (b)(4) , lot 3578992, rma 268895.Inspection: visual inspection confirms missing screw from housing assembly.Refer to attachment.Product history: review of device history records indicate that 30 devices were manufactured under lot 3578992 and 0 devices were accepted into final stock on 05/23/2017.Review of qt 17-05-0089 revealed that all the part was disposition "accept per specification / use as is" on (b)(6) 2017.Non-conformance was not related to the failure alleged in this compliant.Complaint history review: a review of complaints in trackwise related to p/n (b)(4) , lot number 3578992 shows 00 additional complaints related to the failure in this investigation.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.Conclusion: visual inspection confirms failure of screw disassociation.
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Search Alerts/Recalls
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