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	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received on 2/23/2024 reporting "on 12/20/2023 we had an injury at the roi cps, llc facility due to a blade becoming exposed prior to use." the sample was not returned for evaluation.A supplier corrective action request (scar) was issued to the safety scalpel supplier s & s surgical products.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
On (b)(6) 2023 we had an injury at the roi cps, llc facility due to a blade becoming exposed prior to use.
Additional Manufacturer Narrative
A complaint was received on 2/23/2024 reporting "on (b)(6) 2023 we had an injury at the (b)(6) facility due to a blade becoming exposed prior to use." the sample was not returned for evaluation.Deroyal performed a review of inventory on hand, no issues of this nature were found.A supplier corrective action request (scar) was issued to the safety scalpel supplier s & s surgical products.The supplier reported that there were no issues during the manufacturing process.A potential root cause has been identified to be "product shifting during transit." all shipments of safety scalpels are labeled with a bright orange label stating "caution blades may become exposed during transit).Deroyal will continue to monitor through the complaint handling system.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: #11 SAFETY SCALPEL, NS, #11 NEW DESIGN, BULK, NS
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 hwy 33 south; new tazewell TN 37825
• Manufacturer Contact: rose earl ; 200 debusk lane; powell, TN 37849 ; 8653621051
• MDR Report Key: 18905548
• Report Number: 2320762-2024-00012
• Device Sequence Number: 12734405
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: D4511A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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