MAUDE Adverse Event Report: ZIMMER INC ZIMMER AIR DERMATOME COMPLETE KIT; ZIMMER DERMATOMES

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 07/22/2014

Event Type  Injury  

Event Description

Risk was notified that a surgeon was attempting a skin graft with two loaner zimmer dermatomes and both caused a skipping effect across the skin.This caused fragmented skin retrieval, therefore, causing the skin to not be usable.The surgery was aborted.The donor sites were cleaned and dressed.The pt came back 2 days later and the stsg was performed successfully and since then the pt has been discharged home.The info on the dermatomes are as follows.Sn (b)(4).We have been in contact with (b)(4) from zimmer.

• Brand Name: ZIMMER AIR DERMATOME COMPLETE KIT
• Type of Device: ZIMMER DERMATOMES
• Manufacturer (Section D): ZIMMER INC; p.o. box 798; 1800 west center st; warsaw IN 46581
• MDR Report Key: 4152003
• MDR Text Key: 16778514
• Report Number: 4152003
• Device Sequence Number: 1
• Product Code: GFD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2014
• Distributor Facility Aware Date: 07/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR