MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER DISPOSABLE SCALPELS SIZE 11, NON-STERILE; SCALPEL BLADE

Model Number	371631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.A picture was provided, but the complaint could not be confirmed based on what was in the picture.The most likely root cause is a manufacturing error, however without a sample to evaluate it cannot be confirmed.User error may also have caused the blade breakage due to excessive force.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 "scalpel blade broke off in patient, mount for blade to handle broke.The scalpel broke off in the patient while cutting tissues and had to be removed.".

• Brand Name: BARD-PARKER DISPOSABLE SCALPELS SIZE 11, NON-STERILE
• 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: 25174175
• Report Number: 3002750084-2026-00046
• Device Sequence Number: 10181926
• Product Code: GES
• UDI-Device Identifier: 00840113202478
• UDI-Public: 00840113202478
• 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): 05/14/2026

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: 371631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/14/2026
• 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