MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER DERMATOME

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

Event Date 08/16/2023

Event Type  Other  

Event Description

Physician took autograft from the patient.She was using the zimmer dermatome with zimmer dermatome blade.Auto graft was taken but it left a "strip/trail of skin" within the graft.Per dr.(b)(6) this made a portion of the graft unusable.Resultant of this, she had to take second graft.Per physician, if the first graft did not have complications the second graft would have not been needed.

• Brand Name: ZIMMER DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 17652618
• MDR Text Key: 322508758
• Report Number: MW5145077
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White