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 Type  malfunction  

Manufacturer Narrative

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

Event Description

An air hose leak has been reported on this unit.No adverse event was reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined that the inner tube was damaged; however, the repair was not completed because the damage cannot be repaired and the hose would need to be replaced.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

The event occurred during surgery.The surgery time was increased by 1-15 min.No harm reported.

• Brand Name: DERMATOME HOSE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10689784
• MDR Text Key: 211756203
• Report Number: 0001526350-2020-00873
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1