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

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Investigation completed.This is an initial final report submission.Review of the most recent repair record determined the head, control bar, thickness control lever, width plates 2 and 4 inch were damaged.The width plates, head, control bar, thickness control lever, motor, eccentric shaft, thickness control shaft, fine adjustment cams, planetary carrier, bearings, spring seal, and other parts were replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that upon inspection the device was found in need of repair.At evaluation investigation the device was found to have a damaged width plate; a reportable malfunction.No adverse events were reported as a result of this malfunction.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11307155
• MDR Text Key: 231143729
• Report Number: 0001526350-2021-00146
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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: 62689593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1