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

Model Number N/A

Device Problem Unclear Information (4052)

Patient Problem Burn(s) (1757)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during surgery there was an area of burn noted on graft donor site when dressing removed.There was harm to the patient and additional intervention was required.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.The following sections were updated/corrected: b4, b5, d4, d10, g4, g7, h2, h3, h4, h6, h10.Review of the most recent repair record determined that the unit's control bar had some side play.The control bar was recalibrated and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

There is no additional information.

Manufacturer Narrative

This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, g4, g7, h2, h10.

Event Description

The event occurred 3 times in the same procedure.

• 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: 10458746
• MDR Text Key: 204517303
• Report Number: 0001526350-2020-00719
• 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
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 63123397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other