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

Model Number N/A

Device Problems Power Problem (3010); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Concomitant medical products: item# 00880100200, dermatome hose, lot# 555350.Air dermatome handpiece :product review of the zimmer air dermatome serial number (b)(4) by a zimmer biomet certified service repair technician on 28 february 2020 revealed that the unit¿s rpms were not in specification, the control bar was not in the correct position and the calibration was out at the 0 reading.Repair of the device was performed by a zimmer biomet certified service repair technician on 28 february 2020.The device, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.

Event Description

It was reported that during case set-up the handpiece didn't allow proper flow of nitrogen through it for power.No harm or delay was reported.Investigation showed the rpm's were low and outside of specifications.There was no adverse event 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: 10478592
• MDR Text Key: 205473006
• Report Number: 0001526350-2020-00742
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)160623(10)63394127
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 63394127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• 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