MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; GENERAL SURGERY TRAY

Model Number	89-5400
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While setting up operating room for total knee arthroplasty, it was discovered that the deroyal miriam total knee pack came with 14 lap pads, instead of 15.This was identified & recorded properly during initial count.Case proceeded as normal, no harm to patient.

• Brand Name: DEROYAL
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk ln.; powell TN 37849
• MDR Report Key: 9451044
• Report Number: 9451044
• Device Sequence Number: 13975757
• Product Code: LRO
• UDI-Device Identifier: 00749756635929
• UDI-Public: (01)00749756635929
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/21/2019
• Report Date (Section F): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 89-5400
• Device Lot Number: 50905191
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/21/2019