Model Number N/A |
Device Problems
Crack (1135); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 a poly trial had a small chip on it during reprocessing.There was no patient involvement.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. h6-component code- suggested code: mechanical (g04) - provisional top.Visual inspection of the returned device found it to exhibit signs of repeated use and a piece is chipped off the device.Review of the device history record identified no related deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history identified no additional complaints for the reported part and lot combination.Medical records were not provided.This complaint is confirmed per device evaluation.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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