MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2024
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 12/13/2024, it was reported by a distributor via email that three ar-2324bcm bio-composite swivelock sp sutures broke in the middle, where it meets the eyelet, during insertion.This was discovered during a procedure on (b)(6) 2024.Additional information received on 12/20/2024: the distributor reported that only one ar-2324bcm bio-composite swivelock sp had issues during this rcr procedure on (b)(6) 2024.The sutures broke after implantation, and the anchors remained in the patient.The case was completed using a new ar-2324bcm bio-composite swivelock sp.The case was delayed ten minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.The most likely causes of the reported failure are improper bone preparation, misaligned tensioning of the suture, and/or excessive force.According to the surgical technique.3.Completely advance the driver into the bone socket, beyond the first laser line, until the anchor body contacts bone.Evaluate suture tension.If tension is not adequate, back the driver out and readjust the tension.4.Make sure the tip of the anchor body is in contact with bone.Hold the thumb pad steady and rotate the driver handle clockwise to insert the anchor body until it is flush with the bone.5.Cut the fibertape suture tails with a fibertape cutter.Repeat these steps for the second lateral anchor note: do not attempt to apply tension to the sutures with the eyelet in the bone socket.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• 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: 21125659
• Report Number: 1220246-2025-09354
• Device Sequence Number: 7676938
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: (01)00888867026865(11)240501(17)280430(10)15242513
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K191226
• 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): 07/10/2025

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 SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 15242513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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