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

Model Number N/A

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Telephone number: (b)(6).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during a surgery but before use the handpiece felt stiff and was taking very thin grafts.There was no harm to the patient reported but there was a delay of 1-15 minutes.No adverse events were reported as a result of this malfunction.

Event Description

An additional skin graft was required from the patient.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

This event occurred during biomedical engineering test check.There was no harm or delay reported and an alternate device was available for use.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Once the investigation is complete, a follow up/final report will be submitted.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.

• 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: 10898669
• MDR Text Key: 218217408
• Report Number: 0001526350-2020-00996
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other