MAUDE Adverse Event Report: Arthrex, Inc. SWVLK TENO BIO-COMP 9X 19.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWVLK TENO BIO-COMP 9X 19.5MM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 16-jul-26, arthrex was notified of a case report published in jses reviews, reports, and techniques by pellicer-garcia et¿al., conducted at general university hospital virgin of the lilies, alcoy, spain.The publication reports a case of simultaneous musculocutaneous nerve entrapment and radial nerve traction injury following open subpectoral biceps tenodesis using an arthrex biocomposite swivelock 9 × 19.5 mm.Immediately following surgery, the patient exhibited weak elbow flexion, complete paralysis of wrist and finger extension, weak supination, and sensory loss consistent with combined musculocutaneous and radial nerve palsy.Ultrasound and revision surgery confirmed entrapment and compression of the musculocutaneous nerve beneath the tenodesed tendon.Revision surgery was performed, including removal of the interference screw, reversal of the tenodesis, and neurolysis of the musculocutaneous nerve.The patient experienced progressive neurological recovery and had resumed almost normal daily activities approximately one year after the initial surgery.
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 9X 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: 50155979
• Report Number: 1220246-2026-04215
• Device Sequence Number: 9103423
• Product Code: MAI
• UDI-Device Identifier: 00888867020597
• UDI-Public: 00888867020597
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SWVLK TENO BIO-COMP 9X 19.5MM
• Device Catalogue Number: AR-1662BC-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown