MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. NEEDLE 1/2 TAPER POINT MAYO CATGUT 0.050X1.404; DISPOSABLE SUTURING NEEDLE

Model Number	216735
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for evaluation.The model number and lot number were provided, but no pictures were provided.The investigation is ongoing.Once we have completed the investigation, a supplemental report will be submitted with any additional relevant information.
Event or Problem Description
Complainant alleges "the needle actually snapped off into pieces inside a patient.Thankfully all the pieces were retrieved." patient was having a quadriceps ligament repair.All fragments and pieces were removed from the patient.There was no harm to the patient.
Additional Manufacturer Narrative
Device was not returned for evaluation.No pictures of the device were provided, however part number and lot number were provided.The customer stated that the needle broke at the eyelet during surgery.Without ability to evaluate the sample (or pictures), our ability to investigate is limited.The root cause is undetermined.However, based on historical knowledge of similar complaints, broken needles can occur if the customer holds the needle with a clamp too close to the eye or end point of the needle.The ifu states where to use a clamp, and not to use it near the eye or end of the needle.So most likely, this was user error if that occurred, but it cannot be verified based on the information we have.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: NEEDLE 1/2 TAPER POINT MAYO CATGUT 0.050X1.404
• Common Device Name: DISPOSABLE 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: 21036824
• Report Number: 3002750084-2024-00063
• Device Sequence Number: 15588244
• Product Code: GAB
• UDI-Device Identifier: 00840113217601
• UDI-Public: 00840113217601
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 216735
• Device Lot Number: 331588
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/13/2025
• 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