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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problems Abrasion (1689); Laceration(s) (1946); Skin Tears (2516)

Event Date 10/07/2020

Event Type  Injury  

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 by the surgeon that the dermatome kept skipping resulting in poor graft quality.Attempted three grafts.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).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

There is no additional information.

• Brand Name: ZIMMER AIR DERMATOME, COMPLETE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10791601
• MDR Text Key: 214758830
• Report Number: 0001526350-2020-00930
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 00880100000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 100