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

Model Number N/A

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that an air dermatome had smoke coming out of it.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information is available.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This report is being filed to relay additional information.Udi: (b)(4).The customer returned a zimmer air dermatome serial number (b)(4) for evaluation.Evaluation of the device on 28 august 2019 involved the technician disassembling the device and inspecting every component that could have produced smoke.However, the service technician was unable to find a failure of the device.Repair of the dermatome occurred the same day and involved replacing multiple bearings and the hinge gasket.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.The service technician found no failure mode with the device during evaluation of the product.As such, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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: 8922672
• MDR Text Key: 155262902
• Report Number: 0001526350-2019-00691
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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: 64063528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1