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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation, but a picture of the broken device was provided.The root cause is believed to be a manufacturing deficiency, as it may have been a weak spot in the blade.However, user error may also have contributred due to excessive force being applied which could have caused the breakage.This should be considered the final report.If additional relevant informationn is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we were notified of a complaint from a customer stating blade broke during a procedure.

• 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: 22636122
• Report Number: 3002750084-2025-00035
• Device Sequence Number: 12761032
• Product Code: GES
• UDI-Device Identifier: 00840113201525
• UDI-Public: 00840113201525
• Combination Product (Y/N): N
• 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): 07/28/2025

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: 0426097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/28/2025
• 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