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	07/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 7 sep 2026, a distributor reported via email that one unit of ar-1662bc-7 swvlk teno bio-comp 7 × 19.5 mm batch 15353573 experienced a deployment issue during a biceps repair procedure.During the procedure, the tenodesis swivelock forked eyelet fractured after insertion on (b)(6) 2026.The anchor was initially inserted; however, the surgeon was not satisfied with the tensioning result and attempted to withdraw the anchor for adjustment.Upon removal, the forked eyelet was observed to be broken.A second anchor was subsequently provided and used to complete the repair.The pilot hole had been prepared using an ar-1408l instrument.No device fragments remained in the patient.The procedure was completed successfully using another swivelock device.
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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50843532
• Report Number: 1220246-2026-04840
• Device Sequence Number: 10301523
• Product Code: MAI
• UDI-Device Identifier: 00888867020573
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 09/21/2026

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: 15353573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• 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