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

Model Number N/A

Device Problems Loss of Power (1475); Power Problem (3010)

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

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the device not properly working.The brand new device was delivered and when first plugged in it was running slowly.The event occurred during surgery.After the surgery the device was plugged in again and would not power on.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The customer was asked to return the zimmer air dermatome involved with the event and provide information in order to identify the device; however, the customer did not provide the information requested.As such, no means to identify the product involved can be used to determine if the product was returned or to review the evaluation and repair on the device for the investigation.No evaluation or repair of the device could be reviewed to determine if the event was confirmed.As such, a specific cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information is available.

Manufacturer Narrative

This follow up report is being submitted to report additional information.

Event Description

It was reported that the device was not properly working.The brand new device was delivered and when first plugged in it was running slowly.The event occurred during surgery.No harm or delay occurred.No adverse events were reported as a result of this malfunction.

• Brand Name: ZIMMER AIR DERMATOME, COMPLETE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9153504
• MDR Text Key: 162635967
• Report Number: 0001526350-2019-00858
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00880100000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 10/18/2019; 12/09/2019
• Supplement Dates FDA Received: 11/12/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1