MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/22/2025, an arthrex subsidiary employee reported via email that an ar-2325bcc biocomposite labral swivelock anchor experienced a screw fracture.The break occurred after the thread was tapped twice to accommodate the hardness of the bone before insertion.The case was completed with a replacement ar-2325bcc biocomposite labral swivelock anchor.This was discovered during an mpfl procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 07/29/2025: the case was not delayed, and no additional anesthesia was administered.All fragments were retrieved from the patient.No adverse effects were reported on or after the surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-complaint allegation is not confirmed.-visual inspection of the suture anchor, biocomposite¿ swivelock®, 3.5 x 15.8 mm, vented, identified that the eyelet and screw were not returned with the device.-functional testing was not performed due to the damage to the device.No problem found with the device.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• 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: 22770460
• Report Number: 1220246-2025-03385
• Device Sequence Number: 15849387
• Product Code: MAI
• UDI-Device Identifier: 00888867026957
• UDI-Public: (01)00888867026957(11)241118(17)261031(10)15349117
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/05/2025

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 SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC
• Device Lot Number: 15349117
• 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: 12/03/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown