MAUDE Adverse Event Report: ARTHREX, INC. SWVLK PEEK TENO 8MM W/FORK EYELET; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWVLK PEEK TENO 8MM W/FORK EYELET
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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 26-jan-2026, an arthrex subsidiary employee reported via email that an ar-1662psl-8 swivelock tenodesis suture anchor broke at the tip when it was lightly touched to the bone surface during insertion.No fragments were retained in the patient.The procedure was completed using a replacement ar-1662psl-8 swivelock tenodesis suture anchor.There was no significant delay; no additional anesthesia was administered.This was discovered during a procedure on (b)(6) 2026, with no reported patient harm.

• Brand Name: SWVLK PEEK TENO 8MM W/FORK EYELET
• 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: 24324778
• Report Number: 1220246-2026-00557
• Device Sequence Number: 21213169
• Product Code: MAI
• UDI-Device Identifier: 00888867020658
• UDI-Public: (01)00888867020658(11)231002(17)280930(10)15148515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• 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): 05/13/2026

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: SWVLK PEEK TENO 8MM W/FORK EYELET
• Device Catalogue Number: AR-1662PSL-8
• Device Lot Number: 15148515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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