MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. CARBON RIB-BACK BLADES SIZE 10

Model Number	371110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, nor were any pictures provided.Based on the evaluation conducted, packaging process has established controls to mitigate broken blade condition, the root cause for broken blade condition could be machine related; nonetheless, there are established controls to mitigate this type of condition such as: operator trainings, in-process inspections, 100% visual inspection performed by certified personnel to sort out nonconforming parts prior to final assembly and packaging.Condition could not be confirmed due not sample or photo are available for evaluation.Also, excessive force by end user may cause blade tip breakage.The rootcause is manufacturing error.No rma was issued when complaint was notified to aspen surgical.Broken condition could not be confirmed.Device history record was reviewed and no nonconformance was issued related to complaint condition.Fmea was reviewed.Failure is scored as low risk.Not update was required.A dhr review was completed for product 371110 with lot number 0444331.There were no noted nonconformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification.This should be considered as the final report but if we find any additional information, we will provide a supplemental reeport.
Event or Problem Description
Complaint alleges, "blade broke during use.No patient harm has been reported.".

• Brand Name: CARBON RIB-BACK BLADES SIZE 10
• Common Device Name: BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: raghava bandi ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166997100
• MDR Report Key: 23872589
• Report Number: 3002750084-2025-00068
• Device Sequence Number: 19971532
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 0444331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/22/2025
• 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