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

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Current repair product evaluation product review of the air dermatome serial number (b)(4) by flextronics on (b)(6) 2020 revealed that the needle bearing and external e-rings were worn, there was corrosion on the ball bearings, the swivel was loose, the motor speed was low, and the unit was out of calibration and control bar position not correct.Product repair repair of the device was performed by flextronics on (b)(6) 2020 which included replacement of the following: motor (pn06001810353, ln64223144), swivel (pn06002002156, ln64661050), hinge (pn06001810819, ln64088557), ball bearing (pn06001810357, ln63704694)-2, motor sleeve (pn06001810378, ln642240794), external e-ring (pn06001810395, ln64350690)-2, needle bearing (pn06001810393, ln64581592).Additional repair included recalibration and the position of the control bar the device, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history records identified no deviations or anomalies during manufacturing.Device is 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 the device was making an odd noise, which was observed while checking the instruments prior to surgery.Investigation showed that motor speed was low.No adverse event was 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: 10283586
• MDR Text Key: 199695593
• Report Number: 0001526350-2020-00612
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: 00880100100
• Device Lot Number: 32443300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2000
• 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