MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 27th feb 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-2324bcct, suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with fibertape® loop (blue), its anchor pulled out during insertion.This was detected during a right knee arthroscopic anterior cruciate ligament reconstruction surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-2324bcct.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is not confirmed.-upon visual inspection, it was noted that the anchor of the suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with fibertape® loop (blue) was not returned with the device.The sutures were cut, and the eyelet remains attached to the suture.-functional testing was not performed due to the damage to the device.Per dfu-0087-eo corkscrew®, pushlock®, and swivelock® suture anchors.G.Precautions - 4.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.5.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.6.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 most likely cause(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• Brand Name: BIO-COMP, SWIVELOCK C, FT, 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: 24637391
• Report Number: 1220246-2026-01506
• Device Sequence Number: 18694018
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)241202(17)281130(10)15355206
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/08/2026

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, FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCT
• Device Lot Number: 15355206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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