Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problems
Laceration(s) (1946); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Event Description
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It was reported that the air dermatome was skipping causing harm to the patient.Patient harm was done as it made a full thickness laceration into subcutaneous tissue at the leading edge of the harvest unnecessarily which had to be sutured.Due diligence is in progress, and there is no further information available at this time.No additional consequences have been reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).G2 foreign: canada.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Lot/serial identification is necessary for review of device history records, and lot/serial identification was not provided.A definitive root cause cannot be determined.The event cannot be confirmed.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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Due diligence is complete.No additional event information available.
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Search Alerts/Recalls
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