Model Number N/A |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00151.Medical products: periosteal elevator #853, part# 09-0386, lot# ni.
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Event Description
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It was reported that two (2) elevators were found cracked upon receipt of the product.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.Product was lost post receipt.As a result, visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records; lot identification was not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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