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

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

Dermatome malfunctioned.Was not taking appropriate size tissue.The dermatome skipped and took too much tissue.Another dermatome was obtained and an appropriate amount was taken.Resulted in two graft sites being taken.

• Brand Name: ZIMMER DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 11648070
• MDR Text Key: 244868079
• Report Number: 11648070
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2021,04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11680 DA