MAUDE Adverse Event Report: ARTHREX, INC. SWVLK TENO BIO-COMP 7X 19.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWVLK TENO BIO-COMP 7X 19.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 18-feb-2026, an arthrex subsidiary employee reported via email that an ar-1662bc-7 swivelock tenodesis, biocomposite, 7 mm, with one screw, one fork-tip peek eyelet, and one #2 fiberwire suture experienced an issue during use.The tip of the screw broke upon contact with the bone during implant insertion.No fragments remained in the patient.The procedure was performed on (b)(6) 2026 and completed using a replacement ar-1662bc-7 anchor.There was no significant surgical delay, no additional anesthesia was administered, and no adverse effects or patient harm were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SWVLK TENO BIO-COMP 7X 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: 24567308
• Report Number: 1220246-2026-01340
• Device Sequence Number: 12858122
• Product Code: MAI
• UDI-Device Identifier: 00888867020573
• UDI-Public: (01)00888867020573(11)250710(17)290630(10)15464869
• 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): 06/10/2026

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 TENO BIO-COMP 7X 19.5MM
• Device Catalogue Number: AR-1662BC-7
• Device Lot Number: 15464869
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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