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

Model Number	216701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "we used the following needle on the (b)(6) 2025, a fragment of the needle broke off during surgery.The consultant surgeon operating made the clinical decision to leave the fragment in the patient as the risks to remove it were high.".
Additional Manufacturer Narrative
The actual device is available for evaluation, and is in process of being returned.The model number and lot number of the device were also provided.The investigation is ongoing.Once we have completed the investigation, a supplemental report will be submitted with any additional relevant information.
Additional Manufacturer Narrative
The device was returned for evaluation.This needle broke at the eye portion.This typically occurs when the customer is holding the needle with the clamp there, as it cannot withstand the pressure.The ifu includes instructions to avoid breakage, by indicating that the needle clamp must be used on the flat portion of the needle.If the clamp is used too close to the eye of the needle, it will break, which is what appears to have happened in this case.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 CATGUT STERILE
• Common Device Name: SUTURING 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: 21421827
• Report Number: 3002750084-2025-00004
• Device Sequence Number: 7913294
• Product Code: GAB
• UDI-Device Identifier: 00840113217663
• UDI-Public: 00840113217663
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 216701
• Device Lot Number: 274108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• 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