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

Lot Number 05625348

Patient Problem Laceration(s) (1946)

Event Date 07/26/2023

Event Type  Injury  

Event Description

During the procedure they went to harvest and graft and the graft cut was incomplete.Another dermatome was requested.The donor site on the patient was noted to have intact skin in the middle of the site indicative of the dermatome blade not engaging the skin.The skin from the pass was also torn and did not come off in one uniform piece.Permanent harm to patient.

• Brand Name: DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 17754877
• MDR Text Key: 323489039
• Report Number: 17754877
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 05625348
• 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: 08/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other