MAUDE Adverse Event Report: ARTHREX, INC. LOOP 'N' TACK SUTURE PASSER; MANUAL INSTR, GENERAL SURGICAL

Model Number	LOOP 'N' TACK SUTURE PASSER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/24/2025, it was reported by a sales representative via (b)(4) that an ar-4068lnt loop 'n' tack suture passer tip broke while trying to pass a suture in the labrum.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
One unpackaged ar-4068lnt, batch 15439773, was received for investigation.Visual inspection confirmed that the tip of the shaft was fractured.Functional testing could not be performed due to the condition of the device.The most likely cause of the reported failure is off-axis insertion or prying and leveraging the device, combined with excessive force during use.The complaint allegation is confirmed.
Additional Manufacturer Narrative
The complaint device was not received for evaluation.Based on the provided information, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes prying or levering the device during use, which resulted in the device breaking and/or being damaged.Since the complaint device was not returned and no evidence of the failure was provided, neither physical inspection nor a review of images could be performed.As a result, the complaint allegation could not be confirmed.

• Brand Name: LOOP 'N' TACK SUTURE PASSER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23466144
• Report Number: 1220246-2025-04990
• Device Sequence Number: 18624808
• Product Code: LXH
• UDI-Device Identifier: 00888867367333
• UDI-Public: (01)00888867367333(11)250521(17)300430(10)15439773
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: LOOP 'N' TACK SUTURE PASSER
• Device Catalogue Number: AR-4068LNT
• Device Lot Number: 15439773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 03/02/2026; 03/13/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 03/05/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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