MAUDE Adverse Event Report: ARTHREX, INC. 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
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 07/08/2025, a sales representative reported via (b)(4) that an ar-1926pssp 3.5 mm self-punching pushlock® anchor pulled out and broke.This occurred during a rotator cuff repair procedure when the anchor pulled out and broke.They were able to remove the implant and replace it with the same part number successfully.The patient was not harmed, and the procedure was able to continue and be completed.
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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22667300
• Report Number: 1220246-2025-03156
• Device Sequence Number: 3716642
• Product Code: MAI
• UDI-Device Identifier: 00888867395220
• UDI-Public: (01)00888867395220(11)240228(17)290131(10)15213407
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K221099
• 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): 10/15/2025

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: 3.5MM PUSHLOCK, PEEK, SELF-PUNCHING
• Device Catalogue Number: AR-1926PSSP
• Device Lot Number: 15213407
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown