MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME

Model Number 00-8800-000-10

Patient Problem Insufficient Information (4580)

Event Date 09/26/2023

Event Type  Injury  

Event Description

Dr.Was using a zimmer blade that today shredded a graft.Of note, this device was part of a recall (2023090070) and this product was discovered to be one of the impacted products not removed from our site.Site found two additional recalled blades in a storage room and are modifying their recall response and following mfg instructions for the recall with these products.Manufacturer response for surgical saw blade, zimmer blade (per site reporter).

• Brand Name: DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave; dover OH 44622
• MDR Report Key: 18255498
• MDR Text Key: 329588351
• Report Number: 18255498
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-8800-000-10
• Device Catalogue Number: 00-8800-000-10
• Device Lot Number: 65599469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other