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

Model Number N/A

Device Problems Corroded (1131); Component Missing (2306); Naturally Worn (2988); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that during maintenance the unit had a worn needle bearing and screws need to be replaced.The missing hinge needed to be replaced and the corroded ball bearings need to be replaced.There was a defective motor with low motor speed that also need to be replaced and a defective swivel need to be replaced.There was no patient involvement and the device was only sent in for maintenance.No adverse event was reported as a result of this malfunction.

Event Description

There is no additional information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the device had low motor speed, a loose swivel, possible corrosion on the ball bearings, the hinge gasket was missing, and the needle bearing and screws were worn.The motor, sleeve, swivel, ball bearings, hinge gasket, needle bearing, and screws were replaced and resolved the reported issue.It was noted that the unit has not been previously returned for preventative maintenance.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11641159
• MDR Text Key: 244636068
• Report Number: 0001526350-2021-00431
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: 31788600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1