MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 17th nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1922ps, suture anchor, pushlock® 4.5 x 24 mm, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1922ps.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-1922ps, batch number 15349430, was received for investigation.Upon visual inspection, the eyelet of the suture anchor, pushlock® 4.5 x 24 mm was returned broken.Functional testing was not performed due to damage to the device.The method of bone preparation and the quality of the bone encountered were not provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.Per dfu-0087-eo rev 5 - g precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.

• Brand Name: SUTURE ANCHOR, PUSHLOCK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 23718014
• Report Number: 1220246-2025-05419
• Device Sequence Number: 12973135
• Product Code: MBI
• UDI-Device Identifier: 00888867022959
• UDI-Public: (01)00888867022959(11)241118(17)291031(10)15349430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K251145
• 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,Followup
• Report Date (Section B): 03/03/2026

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, PUSHLOCK
• Device Catalogue Number: AR-1922PS
• Device Lot Number: 15349430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown