MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL BLADE SIZE 15 STERILE; SCALPEL BLADE

Model Number	371215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.Without pictures or a device to evaluate the complaint could not be confirmed and the root cause is uncertain.The root cause could be machine related, even though there are established controls to mitigate broken blades.The root cause could also be excessive force by the end user, causing the blade to break.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 "when the surgeon was making an incision in the concha bullose the 15 blade broke in half and fell down into the sinus cavity.The surgeon was able to retrieve the blade with the scope and suction and both pieces were compared to ensure the entire blade was removed.".

• Brand Name: BARD-PARKER STAINLESS STEEL BLADE SIZE 15 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: 24070962
• Report Number: 3002750084-2026-00004
• Device Sequence Number: 18486879
• Product Code: GES
• UDI-Device Identifier: 00840113204380
• UDI-Public: 00840113204380
• 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): 01/14/2026

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: Health Professional
• Device Model Number: 371215
• Device Lot Number: 0414689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/14/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female