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

Model Number N/A

Device Problem Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Investigation is completed.This is an initial final report.Review of the most recent repair record determined the motor was erratic, control bar not in the correct position, calibration out at all readings, hose was not a zb hose, and the 3 inch width plate, control bar, and head had damage.The control bar, motor, hose, width plate, and head were replaced and device re-calibrated and resolved the reported issue.It was noted that the device has not been regularly returned for annual pm.The zimmer air dermatome should be returned every 12 months for inspection and preventative maintenance.Annual factory calibration checks are strongly recommended to verify continued accuracy.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that during testing the device did not work properly.At evaluation investigation the device was found to have a damaged width plate.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: 10727008
• MDR Text Key: 212741168
• Report Number: 0001526350-2020-00888
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 00880100100
• Device Lot Number: 30343400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1