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

Model Number	216705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "eye of needle broke off during use.".
Additional Manufacturer Narrative
The device was not returned for evaluation, however pictures were provided so the complaint could be confirmed.The fracture occurred at the needle's eye portion.Clamping the needle at or near the eye can cause damage.The ifu directs users not to clamp the needle at the eye for this reason.The most likely cause is due to the user clamping the needle near the needle eye.This should be considered the final report.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 NEEDLES
• 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: 23771733
• Report Number: 3002750084-2025-00065
• Device Sequence Number: 18563792
• Product Code: GAB
• UDI-Device Identifier: 00840113217564
• UDI-Public: 00840113217564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: 216705
• Device Lot Number: 425923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 12/10/2025
• 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 Age: 55 YR
• Patient Sex: Female