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 04/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: canada.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 that during sterilization activities, the techs found the instrument fractured.It is not known when the fractures occurred.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information. visual examination of the returned item and found it to exhibit signs of repeated use nicked / gouged / wear and has piece(s) fractured off.The device has a possible field age of over 10 years.No further analysis can be made.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.This complaint can be confirmed based on the returned devices.The devices have a potential field age of over 10 years and exhibit signs of repeated use.The root cause of the event is attributed to wear and tear of the device from repeated use over time.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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Search Alerts/Recalls
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