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 Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2025
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 22nd july 2025, it was reported by a distributor via email that for an ar-2324bcctt, suture anchor, biocomposite swivelock® c vented 4.75 x 19.1 mm, with tig ertape® loop suture (white/black), the swivelock screw was unable to be inserted into talus after repeatedly tapping step in deltoid reconstruction case.The screw thread was damaged and could not be implanted.This was detected during use in an atfl & deltoid reconstruction procedure on (b)(6) 2025.The procedure was completed successfully as an additional swivelock was used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.Per dfu-0087-eo - g.Precautions: pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.Pushlock and swivelock suture anchors only: ensure that the anchor body is in full contact with the bone before advancing the anchor body into the prepared bone socket.The quality of the bone encountered was not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22749906
• Report Number: 1220246-2025-03356
• Device Sequence Number: 18305573
• Product Code: MAI
• UDI-Device Identifier: 00888867026858
• UDI-Public: (01)00888867026858(11)250217(17)290131(10)15390279
• 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,Followup
• Report Date (Section B): 11/20/2025

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: 15390279
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown