MAUDE Adverse Event Report: ARTHREX, INC. NEEDLE, SPRING EYE, 60 MM; DISPOSABLE SUTURING NEEDLE

Model Number	NEEDLE, SPRING EYE, 60 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8/4/2025, an fda medwatch notification was received via email.A facility representative reported that during a procedure on (b)(6) 2025, the tip of an ar-7283 spring eye needle broke off during use.All broken fragments were successfully recovered, and the patient was not adversely affected.Additional information was received on 08/15/2025: this event occurred during a left hip abductor rupture repair procedure on (b)(6) 2025.It is unclear whether the issue originated on the back table or inside the patient.The procedure was completed without complications by utilizing an alternative needle.There was no delay in the case, and no additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-7283 batch 25271 was received for evaluation.Visual inspection revealed that the needle eye was broken off.The needle shows burrs on the surface.A functional test cannot be performed due to damage to the device.The most likely cause of the reported failure was the reuse of the needle and/or the device coming into contact with another instrument during use.

• Brand Name: NEEDLE, SPRING EYE, 60 MM
• Common Device Name: DISPOSABLE SUTURING NEEDLE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22872514
• Report Number: 1220246-2025-03584
• Device Sequence Number: 10424655
• Product Code: GAB
• UDI-Device Identifier: 00888867207943
• UDI-Public: (01)00888867207943(11)210901(17)260831(10)25271
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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 Expiration Date: 08/31/2026
• Device Model Number: NEEDLE, SPRING EYE, 60 MM
• Device Catalogue Number: AR-7283
• Device Lot Number: 25271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown