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ZIMMER AIR DERMATOME Adverse Event — Malfunction (MDR 0001526350-2020-00418)

ZIMMER AIR DERMATOME Adverse Event — Malfunction (MDR 0001526350-2020-00418) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZIMMER AIR DERMATOME; Generic name: DERMATOME; Manufacturer: ZIMMER SURGICAL, INC..

DeviceZIMMER AIR DERMATOME
Generic nameDERMATOME
ManufacturerZIMMER SURGICAL, INC.
Report number0001526350-2020-00418
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, USER F
NarrativeTHIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PRODUCT REVIEW OF THE AIR DERMATOME SERIAL NUMBER (B)(4) BY ZIMMER BIOMET (B)(4) ON 7 APRIL 2020 REVEALED THAT THE MOTOR WAS ERRATIC, THE DEVICE WAS OUT OF CALIBRATION AND MULTIPLE PARTS HAD VISIBLE WEAR AND NEEDED TO BE REPLACED. REPAIR OF THE DEVICE WAS PERFORMED BY ZIMMER BIOMET (B)(4) ON 7 APRIL 2020 WHICH INCLUDED REPLACEMENT OF THE
SourceopenFDA MAUDE (device adverse events)

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