Catalog Number 046W0AN00002 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 3003853072-2020-00117, 3003853072-2020-00118, 3003853072-2020-00119 and 3003853072-2020-00120.
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Event Description
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It was reported that four instinct java plugs stripped their threads during an operation.The doctor used other plugs complete the operation, and there was no reported patient harm or injury; however, the surgery was delayed for 10 minutes.This is report three of four for this event.
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Manufacturer Narrative
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Added information to h6: component, type of investigation, investigation findings, and investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for the returned instinct java blockers (pn: 046w0an00002) for the failure of deformation.Visual inspection revealed all four returned devices have hex/drive mechanism damage and outer thread damage.Medical records were not provided for review.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the blockers were being used or handled at the time of the damage.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions are required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that four instinct java plugs stripped their threads during an operation.The doctor used other plugs complete the operation, and there was no reported patient harm or injury; however, the surgery was delayed for 10 minutes.This is report three of four for this event.
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Search Alerts/Recalls
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