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

Model Number N/A

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the hand piece blade rattles when attached to handle.It would catch the skin and prevent smooth glide of the dermatome.It would also create skip areas once harvest begins.A delay of 0-10 minutes to obtain a second skin graft 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).Review of the most recent repair record identified no repairs related to the reported event.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
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11710280
• MDR Text Key: 247086471
• Report Number: 0001526350-2021-00479
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 33163800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other