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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 qty.2 of an ar-1926pssp 3.5 mm self-punching pushlock anchor had an issue during a rotator cuff repair procedure on (b)(6)2025.The first anchor was implanted in the normal fashion, but the eyelet broke off during insertion.The eyelet, anchor, and sutures were removed from the patient.The second anchor was implanted into the same hole, and again, the eyelet broke off during insertion.That eyelet, anchor, and sutures also were removed from the patient, there was no harm.A new pilot hole was pre-punched, and an ar-2324bcc suture anchor, biocomposite swivelock, with an unknown lot number, was implanted instead.The procedure was completed successfully.The complaint devices were discarded, and no pictures were taken.There was no case delay, and no additional anesthesia was administered.This occurred during use 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.Per dfu-0362-eo g.Precautions: pushlock only: ensure that the anchor body is in full contact with the bone before advancing the anchor body.Swivelock only: do not use excessive force when inserting the eyelet into bone to avoid device damage.If device is not advancing after repeated malleting, a pilot hole should be created.If the eyelet becomes unusable after repeated malleting, discard it and use a new implant.Ensure that the angle of anchor insertion is perpendicular to the bone.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging 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: 21652125
• Report Number: 1220246-2025-01053
• Device Sequence Number: 18450413
• Product Code: MAI
• UDI-Device Identifier: 00888867395220
• UDI-Public: (01)00888867395220(11)240814(17)290731(10)15302293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/14/2025

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: 15302293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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