MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING; NON-DEGRADABLE FIXATN FASTENER

Model Number	3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-1926pssp 3.5 mm self-punching pushlock anchor broke off the inserter during insertion.The broken piece was retrieved from the patient, and an ar-2324pslc suture anchor, peek-swivelock c, 4.75 x 19.1 mm was used as a replacement.Subsequently, two ar-19032c fiberstitch rc implant 1.5 devices were unable to seat after deployment.All sutures and anchors were removed from the patient, and a replacement ar-19032c fiberstitch rc implant 1.5 from a different lot was used to complete the case.The procedure was delayed by approximately five minutes.This occurred during a surgery on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23943675
• Report Number: 1220246-2026-00012
• Device Sequence Number: 20819850
• Product Code: MBI
• UDI-Device Identifier: 00888867395220
• UDI-Public: (01)00888867395220(11)210825(17)260731(10)14001551
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251145
• 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
• Report Date (Section B): 04/14/2026

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 Expiration Date: 07/31/2026
• Device Model Number: 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
• Device Catalogue Number: AR-1926PSSP
• Device Lot Number: 14001551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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