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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 01/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (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 is reported that the instrument was discovered fractured during restocking.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were corrected h6 - health impact.A visual inspection was conducted on the returned depth gauge.The gauge shows signs of multiple uses including heavy marking and scratching on the gauge surface.Further inspection was conducted on the gauge tip.The tip for the depth gauge has fractured.The fractured version on the depth gauge was not returned.A determination cannot be made as to what caused the device to fracture.Dhr review was not performed as product has approximate field age of 15 years, with an unknown number of uses.The device shows signs of repeated use.A definitive root cause cannot be determined.The reported event is confirmed, based on evaluation of the returned product.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 is available at the time of this report.
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Search Alerts/Recalls
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