MAUDE Adverse Event Report: Arthrex, Inc. 2.9MM BIOCOMP PUSHLOCK, DX; BIO SOFT TISSUE FIXATN FASTNR

Model Number	2.9MM BIOCOMP PUSHLOCK, DX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, it was reported by an arthrex employee via email that for an ar-8923bc, suture anchor, biocomposite pushlock®, short, dx 2.9 x 12.5 mm, while a 2 mm suturebutton tape was threaded through the distal eyelet, tension was applied to the tape during insertion.The eyelet fractured and detached from the device.At the time tension was applied, the eyelet was in contact with the bone.This was detected during use in unknown procedure on (b)(6) 2026.The procedure was completed successfully using a newly opened product with the same part number.No significant surgery delay reported.No additional anesthesia administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 2.9MM BIOCOMP PUSHLOCK, DX
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50473242
• Report Number: 1220246-2026-04503
• Device Sequence Number: 21360390
• Product Code: MAI
• UDI-Device Identifier: 00888867131491
• UDI-Public: (01)00888867131491(11)251125(17)271031(10)15535412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K253931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 2.9MM BIOCOMP PUSHLOCK, DX
• Device Catalogue Number: AR-8923BC
• Device Lot Number: 15535412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown