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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the dermatome hose was leaking air somewhere and the dermatome was not working as it should; occurred during testing of the machine prior to surgery.No adverse events were reported as a result of this malfunction.There was no patient involvement, no harm, no delay.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The event cannot be confirmed.Device is used for treatment.A definitive root cause cannot be determined.H3 other text: discarded.

Event Description

No additional event information available.

• Brand Name: DERMATOME HOSE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10507704
• MDR Text Key: 206124061
• Report Number: 0001526350-2020-00757
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: 00880100200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1