MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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
It was reported that during a shoulder stabilization surgery the anchor broke off during insertion.No part of the device remained inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-2922ps, pushlock®, batch 15454409, was received for investigation.Visual evaluation noted that the anchor was broken and the eyelet was missing.No fragments were returned for investigation.Functional testing could not be performed due to the damage to the device.The most likely cause of the reported failure is improper bone preparation, misaligned insertion, or prying /leveraging the device.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
• 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: 23888179
• Report Number: 1220246-2025-05803
• Device Sequence Number: 17311202
• Product Code: MBI
• UDI-Device Identifier: 00888867027992
• UDI-Public: (01)00888867027992(11)250623(17)300531(10)15454409
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K251145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: SUTURE ANCHOR, 2.4MM PUSHLOCK , PEEK
• Device Catalogue Number: AR-2922PS
• Device Lot Number: 15454409
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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