Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that while tightening the trial cone to the distal body the hex driver tip broke off.The broken piece was located and removed from the field.There were no harm or health consequences to the patient.It was reported that further information is available.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d4; g3; h2; h3; h4; h6 visual examination of the returned product identified the driver has been scuffed such that rings are present around the distal shaft.Discoloration spots were observed on the grip.The tip of the hex driver is fractured.Additionally, the features of the fracture surface visually align with zrm in which a bending overload fracture failure mode was identified.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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