Model Number N/A |
Device Problem
Incorrect Measurement (1383)
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Patient Problems
Abrasion (1689); Suture Abrasion (2497); Localized Skin Lesion (4542)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that when the surgeon was ready to take skin graft, thickness dial was adjusted by surgeon.Upon using the dermatome the surgeon noticed it was taking extra thickness graft, not what it had been set at.The blade was changed by theatre nurse and tried again.The same thing happened.Wounds were sutured.A second dermatome was used and the blade and plate were set up by theatre nurse and double checked by surgeon.This one worked fine and grafts were taken from patients opposite leg, but the patient was fine.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).Review of the most recent repair record determined that the control bar was out of calibration and not in the correct position.The control bar was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Event Description
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There is no additional information.
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Search Alerts/Recalls
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