Catalog Number 046W0AN00002 |
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 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Establishment name: (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 3003853072-2020-00110.
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Event Description
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It was reported that during the surgery, two blockers stripped.A third blocker was successfully used.There were no impacts on the patient.This is report two of two for this event.
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Manufacturer Narrative
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Added information to h6: type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for the failure of stripped/damaged threads.This device is used for treatment.No medical records were provided with the complaint.Inspection the identities of the returned devices match information in the complaint file.Visual inspection of the closure top reveals that both have fractured outer threads.Dhr review the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.It is possible that the blockers were cross-threaded into the mating pedicle screws during attempted installation.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 during the surgery, two blockers stripped.A third blocker was successfully used.There were no impacts on the patient.This is report two of two for this event.
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Search Alerts/Recalls
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