ZIMMER DERMATOME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for ZIMMER DERMATOME manufactured by Zimmer Surgical, Inc..

Event Text Entries

[181739577] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093419
• MDR Report Key: 9775040
• Date Received: 2020-02-28
• Date of Report: 2020-02-26
• Date Added to Maude: 2020-03-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER DERMATOME
• Generic Name: DERMATOME
• Product Code: GFD
• Date Received: 2020-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER SURGICAL, INC.
• Manufacturer Address: OH 44622 US 44622

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-28