MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS; HANDLE, SCALPEL

Model Number	D4511A
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "we were notified of a complaint from a customer stating dull instruments.".
Additional Manufacturer Narrative
A distributing facility reported, "we were notified of a complaint from a customer stating dull instruments." deroyal industries, inc.Requested return of the device, however it was stated to be unavailable.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.

• Brand Name: #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 164 giles hollow road; rose hill VA 24281
• Manufacturer (Section G): DEROYAL INDUSTRIES INC.; 164 giles hollow road; rose hill VA 24281
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 25620320
• Report Number: 1123071-2026-00001
• Device Sequence Number: 21105862
• Product Code: GDZ
• UDI-Device Identifier: 00749756645386
• UDI-Public: 00749756645386
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: D4511A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/25/2026
• 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