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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problems Injury (2348); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that skin was pulled off the patient.No other information was provided, nor could any be attained.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 udi: (b)(4).H6 patient code: 2348 injury.There was injury reported, however, it is unknown how the patient was harmed.This medwatch is being filed to relay additional information.Investigation complete.This is a final submission.Correction made as this is a serious injury event, even thought the injury is not identified.Product evaluation: product review of the air dermatome (b)(6) by dover on (b)(6) 2020 revealed that the control bar was not in the correct position which could have resulted in the pulled skin and the calibration was out at the 0 reading.Product repair: repair of the device was performed by dover on (b)(6) 2020 which included replacement of the following: vespel and semi-circle bearings.Additional repair included recalibration the device, serial number (b)(6), was then tested and functioned properly.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that during surgery the device pulled some skin of the patient.There was unknown harm to the patient.There was no delay in surgery and no additional procedure required.No additional event information available.

• 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: 9852709
• MDR Text Key: 186695715
• Report Number: 0001526350-2020-00291
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: 64581488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other