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 07/19/2021 |
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 report 3012447612-2021-00302.
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Event Description
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It was reported that two screws disassembled intra-op after being removed to change their trajectories.The rod and closure tops had already been installed when the surgeon decided to change the screws' trajectories.New screws were used to complete the procedure without reported patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Inspection visual inspection revealed the tulips of both returned screws have disassembled from the screw shanks.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause with the given information, the definitive cause cannot be determined.Device use this device is used for treatment.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.
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Event Description
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It was reported that two screws disassembled intra-op after being removed to change their trajectories.The rod and closure tops had already been installed when the surgeon decided to change the screws' trajectories.New screws were used to complete the procedure without reported patient impacts.This is report two of two for this event.
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Search Alerts/Recalls
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