Model Number N/A |
Device Problems
Break (1069); Gas/Air Leak (2946)
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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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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete g2: foreign country - france.H3 other text : not returned.
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Event Description
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It was reported that the dermatome was broken as it was impossible to put it in the safety position.The dermatome also had an air leakage within the hose.The event timing was during surgery.There is no harm or delay reported.Due diligence is in progress.
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Event Description
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There is no additional information available.
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Manufacturer Narrative
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Review of the most recent repair record determined he safety lever assembly was deformed.Additionally, the reported air leak could not be confirmed; however, the swivel was loose which may affect device functionality.The repair was not completed due to pending materials.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The event is 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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Search Alerts/Recalls
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