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 Date 10/04/2023 |
Event Type
Injury
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Event Description
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It was reported that during the surgery, a broken tray cover was found in the revitan auxiliary equipment loan kit when the patient was already anesthetized.The surgeon, due to the integrity of the equipment, stopped and postponed the surgery.The surgery was completed approximately 12 days later.There is no reported harm or injury to the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).G2: foreign: france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00581 and 0009613350-2023-00582.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: tray.Visual examination of the provided pictures identified that the trays were fractured.A review of the device manufacturing records could not be performed due to missing lot numbers.With the available information, a definitive root cause could not be determined.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.H3 other text : lot number unknown.
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Event Description
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No additional event information to report at this time.
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Search Alerts/Recalls
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