MAUDE Adverse Event Report: Arthrex, Inc. BIO-COMP, SWIVELOCK C, TT, 4.75x19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP, SWIVELOCK C, TT, 4.75x19.1MM
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 7 sep 2026, a distributor reported via email that one unit of ar-2324bcctt batch 15503537 experienced a deployment issue.The issue was identified during an atfl repair procedure performed on 11 may 2026.During the procedure, the swivelock anchor pulled out from the talus site while the plastic handle was being removed.Following removal, the anchor screw was observed to be deformed and could not be reloaded to complete the repair.An additional swivelock anchor was subsequently used to successfully complete the surgery.Ar-1678-01, ar-1678-02, and ar-2324ptb were used for hole preparation.No device fragments remained in the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BIO-COMP, SWIVELOCK C, TT, 4.75x19.1MM
• 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: 50856603
• Report Number: 1220246-2026-04852
• Device Sequence Number: 10053707
• Product Code: MAI
• UDI-Device Identifier: 00888867026858
• UDI-Public: (01)00888867026858(11)250924(17)290831(10)15503537
• 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): 09/22/2026

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: BIO-COMP, SWIVELOCK C, TT, 4.75x19.1MM
• Device Catalogue Number: AR-2324BCCTT
• Device Lot Number: 15503537
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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