MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 18th nov 2025, it was reported by an arthrex's employee via an email that for 2 units of ar-1926ps, suture anchor, pushlock® 3.5 x 19.5 mm, the first unit of ar-1926ps broke and the second unit of ar-1926ps could not be fixed during insertion.This was detected during an ankle ligament reconstruction surgery on (b)(6) 2025.The procedure was completed successfully by using a 3rd ar-1926ps.There were no patient harm and no secondary procedure needed.
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 of the reported failure can be attributed to user error of the device due to improper bone preparation, misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
• 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: 23741782
• Report Number: 1220246-2025-05448
• Device Sequence Number: 10349950
• Product Code: MBI
• UDI-Device Identifier: 00888867023338
• UDI-Public: (01)00888867023338(11)210923(17)260831(10)14193872
• 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): 03/16/2026

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 Expiration Date: 08/31/2026
• Device Model Number: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
• Device Catalogue Number: AR-1926PS
• Device Lot Number: 14193872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown