MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source: foreign - (b)(6).The investigation is still in process.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the unit could not graft thickness properly.The event occurred during surgery.There was no harm or delay that occurred during the event.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the device was not cutting to the proper thickness; motor failure.The motor and various bearings were replaced and resolved the reported issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11083661
• MDR Text Key: 224097914
• Report Number: 0001526350-2020-01117
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 61512460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1