MAUDE Adverse Event Report: ZIMMER, INC. DERMATOME

Catalog Number 00-8800-000-10

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 10/23/2019

Event Type  Injury  

Event Description

Bluf: (bottom line up front) during a skin graft procedure, an unintended laceration occurred due to the incorrect placement of the blade inside the dermatome machine.The blade was removed and replaced correctly.The laceration was repaired, and skin graft procedure completed without additional complications.Patient arrived to the main operating room (or) for skin graft procedure.The surgery resident began debriding the wounds of the left lower extremity of the leg in preparation for skin grafting.The provider attempted to graft the skin using a dermatome just above the knee and realized the blade would not move but cut through to the muscle causing a deep laceration.The procedure was paused with surgical tools remained in place to examine the machine.The surgical team discovered the blade was placed upside down inside the dermatome machine.The warning label was only on one side of the blade.The guard was removed, blade replaced and reloaded correctly.The left thigh laceration was repaired and wound vac was placed.The second attempt of skin graft procedure was completed without any additional complications.Additional information: the zimmer blade fits into the dermatome machine either way with no warning, the warning label of the blade is only located on one side of the blade, the warning label "this side- up" lettering is white with a white background (difficult to read).Request to have a different lettering on the dermatome blade (white lettering with white background).

• Brand Name: DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 9726770
• MDR Text Key: 179946001
• Report Number: 9726770
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2020,12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-8800-000-10
• Device Lot Number: 64357957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19710 DA