MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 29-jan-2026, a sales representative reported via email that an ar-2923bcs short 2.9 mm biocomposite pushlock implant system experienced anchor breakage during insertion.There was no case delay, and it was completed with a replacement ar-2923bcs short 2.9 mm biocomposite pushlock implant system.This occurred during a labral repair procedure on (b)(6) 2026, with no reported patient harm.Additional information was received on 02-feb-2026: all fragments were removed from the patient.
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 improper bone preparation.

• Brand Name: IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24377462
• Report Number: 1220246-2026-00651
• Device Sequence Number: 4837524
• Product Code: MAI
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• 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): 06/08/2026

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: IMPLANT SYS, BIOCOMP 2.9MM PUSHLOCK SHRT
• Device Catalogue Number: AR-2923BCS
• Device Lot Number: 15377394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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