ZIMMER BIOMET, INC. CRUCIATE RETAINING AUGMENTABLE (CRA) CASE ASSEMBLY; INSTRUMENT, KNEE
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Model Number N/A |
Device Problems
Fracture (1260); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
Event Type
Injury
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Event Description
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It was reported that the sterilization tray has cracked or broken legs and several of them are bent with sharp edges causing damage to the sterile drapes.This is a loaner device not a new device.There was a 30 minute delay.This issue was discovered at the start of an initial surgery and as a result of this issue, the operation was suspended and the anesthetized patient had to be woken up.The patient was only anesthetized and was not cut into.Attempts have been made and all available information has been provided.
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Manufacturer Narrative
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(b)(4).G2 : foreign country : poland.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: 0001822565-2023-03135, 0001822565-2023-03136, 0001822565-2023-03236, 0001822565-2023-03238, 0001822565-2023-03239.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as no serious injury has occurred.The initial report was forwarded in error and should be voided.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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