MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Catalog Number 00880100100

Device Problem Failure to Cut (2587)

Patient Problems Suture Abrasion (2497); No Code Available (3191)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.Surgical delay greater than 30 minutes.

Event Description

Customer assures that the blade was right placed, and the set control level adjustment knob pointer was in 0.010 inch.Instead appropriate skin graft, dermatome made big tear to patient´s thigh, which had to be sutured.There was a delay greater than 30 minutes and another device was used for the procedure.No additional patient consequences were reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).On december 27, 2018, it was reported that the dermatome made a big tear to the patient¿s thigh which had to be sutured.The customer assured that the blade was properly placed and the thickness control lever adjustment knob was set to 0.010 inch.The customer returned an air dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated air dermatome serial number (b)(4) as documented in the repair reports.Product review of the air dermatome on march 28, 2019 revealed that the head, swivel, motor, eccentric shaft and bearings all needed to be replaced on the device.The calibration was within specifications and the control bar was in the correct position.The device also operated within motor speed specifications.Repair of the air dermatome was performed by zimmer biomet surgical on march 28, 2019 which included replacement of the head, swivel, motor, eccentric shaft and bearings.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was non-verifiable since during the product review it was noted that the device was within calibration specifications and the control bar was in the correct position.The device also operated within motor speed specifications.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the device was within calibration specifications and the control bar was in the correct position.The device also operated within motor speed specifications.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information available.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8223966
• MDR Text Key: 132296437
• Report Number: 0001526350-2019-00010
• 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
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 61296381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other