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

Model Number	89-2580
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported through a medwatch, "there was not ruler in the pack.".
Additional Manufacturer Narrative
A user facility reported via a medwatch, "there was not ruler in the pack." deroyal industries, inc.Requested return of the device, but it was listed as not available for return.Deroyal reviewed the work order for the lot reported with the complaint and did not find any issues.Employees signed off on adding the ruler to the pack as specified.Inventory was not able to be checked as no inventory was available at distribution and no further inventory is being created as the manufacturing site has closed.The risk analysis was reviewed and was found to be up-to-date and did not require any updates.A complaint to sales ratio was conducted for over the past two years and found to be 0.011%.Root cause: the exact root cause was unable to be determined as no issues were discovered in the production records and without a returned product and no further inventory being produced, no further information could be gathered.Corrective and preventive actions: because the root cause was unable to be determined and because the manufacturing site of the device, lafollette, has closed, no corrective or preventive actions will be taken.There is no other additional information available as the manufacturing site of this product in lafollette, tennessee has been closed.This investigation is complete at this time.No further information is available at this time.We will provide a follow-up report if additional information becomes available.

• Brand Name: SMALL GENERAL PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC..; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23726708
• Report Number: 3005011024-2025-00015
• Device Sequence Number: 18814338
• Product Code: LRO
• UDI-Device Identifier: 50749756281411
• UDI-Public: 50749756281411
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K842648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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: Health Professional
• Device Model Number: 89-2580
• Device Lot Number: 62457410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown