MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BACK BLADE SIZE 10; SCALPEL BLADE

Model Number	371110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not available for evaluation, however pictures were provided to confirm the complaint.Based on the limited information we had to investigation, it appears that excessive force by the end user may have caused the blade breakage.The root cause was user error.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges: "blade broke in half as surgeon was cutting patient, this is a major safety concern and should be reported to the manufacturer aspen.The surgeon was cutting into the patient's soft tissue.No significant delay in procedure, and no injury to patient.".

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADE SIZE 10
• Common Device Name: SCALPEL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 22014455
• Report Number: 3002750084-2025-00018
• Device Sequence Number: 7985496
• Product Code: GES
• UDI-Device Identifier: 00840113201525
• UDI-Public: 00840113201525
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 371110
• Device Lot Number: 0336278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/13/2025
• 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