MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RONGEUR, BEYER, DOUBLE-ACTION, 180 MM; BEYER RONGEUR

Model Number	53-1100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the product stopped working during surgery.The jaws misaligned and did not allow surgeon to grasp.".
Additional Manufacturer Narrative
The device has been returned for evaluation, and the investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was returned for evaluation.Upon visual inspection, it was confirmed that the jaws do not meet evenly.There is an area on the left jaw that is deformed from the right jaw being forcefully pushed into the left jaw when clamping the device.This device should be inspected between uses per reprocessing instructions to ensure that the functionality is not compromised.The root cause is the user not following ifu instructions for customer care and maintenance.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: RONGEUR, BEYER, DOUBLE-ACTION, 180 MM
• Common Device Name: BEYER RONGEUR
• 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: 24513506
• Report Number: 3002750084-2026-00024
• Device Sequence Number: 10303990
• Product Code: HAE
• UDI-Device Identifier: 00887482021750
• UDI-Public: 00887482021750
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 53-1100
• Device Lot Number: 160425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown