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

Model Number	216705
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.The needle broke at the eye portion, which is typically indicative of the customer holding the needle with the clamp close to the eye of the needle, where it cannot withstand that pressure.The ifu indicates where to use a clamp on the needle and that it cannot be used near the eye or tip of the needle.The root cause was determined to be user error, for not following the instructions for use on where to hold the needle.This should be considered the final report.If any additional information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "using the eyed needles to suture the capio sutures-- eyed needle end broke off inside patient second eyed needle package opened-- tip and end broke off inside patient a different larger size of eyed needle (and trocar tip) opened and successfully used all pieces of the eyed needles were found and accounted for-- isolated off the surgical field and sent for mdip.".

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO
• Common Device Name: DISPOSABLE 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: 22819975
• Report Number: 3002750084-2025-00041
• Device Sequence Number: 8756542
• Product Code: GAB
• UDI-Device Identifier: 00840113217564
• UDI-Public: 00840113217564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: 458525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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