MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BACK BLADES SIZE 15; SCALPEL BLADE

Model Number	371115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.The complaint was able to be confirmed by pictures provided by the customer.The root cause may be machine related, however we have controls iin place to mitigate machine errors including operator trainings, in-process inspections, quality inspections, and 100% visual inspection.It may also be due to excessive force applied by the end user as that can cause blade breakage.Based on what we have, the most likely root cause is manufacturing 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 "dr.(b)(6) was in the middle of one of his routine wisdom teeth surgeries when going to use the 15 to open site # 1 the 15 broke in half, as you can see in the picture.Nobody was harmed.".

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15
• 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: 24261535
• Report Number: 3002750084-2026-00009
• Device Sequence Number: 20835537
• Product Code: GES
• UDI-Device Identifier: 00840113201761
• UDI-Public: 00840113201761
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 371115
• Device Lot Number: 0470263
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• 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 Age: 16 YR
• Patient Sex: Female