MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT; SUTURE NEEDLE

Model Number	216704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is ongoing.Once additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the issue is they are bending and breaking the tips off when passing through bone.".
Additional Manufacturer Narrative
The device was not available, but pictures were provided.The intended use of the product is for tissue closure, and improper technique may result in needle breakage.Based on the complaint, the most likely root cause is due to the product being used on bone.Root cause is off-label use.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT
• Common Device Name: SUTURE NEEDLE
• 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: 23916996
• Report Number: 3002750084-2025-00069
• Device Sequence Number: 18428811
• Product Code: GAB
• UDI-Device Identifier: 00840113217588
• UDI-Public: 00840113217588
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 216704
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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