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

Device Problems Defective Component (2292); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The current issue with the newly purchased zimmer dermatomes is as a result of what we believe is a design flaw.The new models have a single locking screw on the underside of the unit to secure in the dermatome blade and protective guard plate.Due to this design, once the screw is tightened in place, there is a very clear centrally located pressure on the floppy blade which ultimately allows for normal apposition at the center of the guard, with blade bending/bowing out at the lateral edges.The result is in varying, non-uniform depths of harvested graft take, skipping, and poor cosmesis.All of our surgeons have appreciated this issue when working with the dermatome, and we no longer are using this newer model because of the results.Fda safety report id # (b)(4).

• Brand Name: ZIMMER DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; OH 44622
• MDR Report Key: 9775040
• MDR Text Key: 181739577
• Report Number: MW5093419
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1