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

Model Number	216701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is in process of being returned for evaluation.Investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "end of the loop of the needle broke off in patient while being used.Surgeon was unable to retrieve broken piece.A substitute needle was used to finish the case.The needle piece was left inside patient.Patient did not require additional treatment.".
Additional Manufacturer Narrative
The actual device was returned for evaluation.After evaluation, the needle broke at the eye portion.Per the ifu, broken needles can occur if the customer holds the needle too close to the eye or end point with clamps.The dhr and analysis results were reviewed, and no irregularities were found.The most likely root cause is user error, from holding the needle too close to the eye.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: SURGICAL 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: 22062702
• Report Number: 3002750084-2025-00019
• Device Sequence Number: 18259938
• Product Code: GAB
• UDI-Device Identifier: 00840113217663
• UDI-Public: 00840113217663
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/02/2025

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: 365815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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