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

Model Number N/A

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that air dermatome was running intermittently.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The customer returned an air dermatome device for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated this air dermatome.Initial qa inspection of the air dermatome was not performed since the customer did not return the device for evaluation.Repair of the air dermatome was not performed by zimmer biomet surgical since the customer did not return the device for the repair process.The reported event was non-verifiable since the device was not returned for evaluation.The root cause of the device running intermittently was non-verifiable since the device was not returned.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 7182567
• MDR Text Key: 97003022
• Report Number: 0001526350-2018-00025
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 33012000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1