Model Number N/A |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports: 3012447612-2020-00591 to 3012447612-2020-00594.
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Event Description
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Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report four of four for this event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information: h3, h6 (methods, results, conclusions).The complaint is unconfirmed for one path finder nxt screw for the reported failure of stripped during implantation but confirmed for damaged tulip head.Visual inspection reveals the screw is deformed with the shaft being disconnected from the tulip.The screw is intact but the top of the tulip is visibly damaged (stripped thread at top of the tulip head).The device was likely conforming when it left zimmer biomet's control.Currently, no action is recommended.
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Event Description
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Two pathfinder nxt closure tops and screws stripped during tightening within surgery.They were removed and replaced with new screws and closure tops to complete the procedure.There were no reported patient impacts.This is report four of four for this event.
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Search Alerts/Recalls
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