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

Model Number	216704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges: "we have had 2 issues with item number 216704 (lot # 324834) a needle style mayo ½ taper where the eyelet will break with the suture.It happened in 2 cases today (b)(6).No injury to patients." note that this report is for the first instance of this malfunction.
Additional Manufacturer Narrative
The actual device is not available for evaluation.The investigation is ongoing.Once the investigation is complete, any additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures were provided so the complaint could not be confirmed.Broken needles can occur if the customer holds the needle too close to the eye or end point with clamps, and the ifu includes this instruction to avoid breakage.The needle broke at the eye, therefore the most likely cause was that the customer must have been holding it with the clamp there, where it cannot withstand that pressure.The root cause is user error.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO, STERILE
• 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: 21712793
• Report Number: 3002750084-2025-00012
• Device Sequence Number: 13279795
• Product Code: GAB
• UDI-Device Identifier: 00840113217588
• UDI-Public: 00840113217588
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 216704
• Device Lot Number: 324834
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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