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

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This is an initial final report.Review of the most recent repair record determined that the connection between the hose and dermatome was not connecting well due to the o-ring being deteriorated and was replaced and resolved the reported issue.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 has been reported that before the surgery this device was found in need of repair because the hand piece would not connect to the hose.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: 10592982
• MDR Text Key: 208757652
• Report Number: 0001526350-2020-00816
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: 31246000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1