Catalog Number 3301-1 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2022 |
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 3012447612-2022-00143 through 3012447612-2022-00145.
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Event Description
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It was reported that three closure tops stripped during final tightening intra-operatively.The closure tops were removed and replaced with alternative closure tops, and another driver was used to complete the procedure without patient impacts.This is report two of three for this event.
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Event Description
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It was reported that three closure tops stripped during final tightening intra-operatively.The closure tops were removed and replaced with alternative closure tops, and another driver was used to complete the procedure without patient impacts.This is report two of three for this event.
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Manufacturer Narrative
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Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no damage to either the screw drives or threads.Potential cause: root cause was unable to be determined as no product issue was identified on the returned devices.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.Device use: these devices are 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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Search Alerts/Recalls
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