Catalog Number 3505-6545 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
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 report 3012447612-2021-00381.
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Event Description
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It was reported that two pathfinder screws disassembled intra-operatively during final tightening.They were removed without patient impacts.This is report one of two for this event.
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Manufacturer Narrative
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Device evaluation: product was not returned, however a photo was provided showing the disassembly.Potential cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied during use.Dhr review per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use these devices are used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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Event Description
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It was reported that two pathfinder screws disassembled intra-operatively during final tightening.They were removed without patient impacts.This is report one of two for this event.
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Search Alerts/Recalls
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