MAUDE Adverse Event Report: ZIMMER, INC. DERMATOME

Model Number 00-8800-000-10

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 03/12/2023

Event Type  malfunction  

Event Description

Concern: ability to use an incorrect blade on the zimmer dermatome device.Both integra & the zimmer blades have two screws in the same location so either blade fits the zimmer machine.No equipment malfunction occurred.Procedure: excisional preparation of penis, split-thickness skin graft, excisional preparation of bilateral lower groins, xenograft to groins & left thigh donor site.Complication occurred when an incorrect blade (integra dermatome) was placed in the zimmer dermatome.This caused a laceration requiring repair.The concern staff have reported is that the integra dermatome blade fits into the zimmer dermatome which, if this error is made (incorrect blade use), can cause harm to the patient.

• Brand Name: DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 17170709
• MDR Text Key: 317554314
• Report Number: 17170709
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-8800-000-10
• Device Catalogue Number: 00-8800-000-10
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other