MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM BC SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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 9/3/2024, it was reported by a sales representative via email that an ar-2324bct-2 biocomposite swivelock anchor broke during insertion.The surgeon drilled with the appropriate size drill and then tapped with the appropriate size tap.When the swivelock was turned into the tibia, the anchor body broke in half, and the eyelet broke as well.Only the internalbrace suture remained in the eyelet.The case was completed using another ar-2324bct-2 biocomposite swivelock.The case was not delayed, and the patient was not affected.This was discovered during an aclr procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information g3, h3, h6 complaint allegation is confirmed per picture attached that showed the anchor and eyelet broken.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 method of bone preparation and the quality of the bone encountered were 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: DBL LOADED 4.75MM BC SWVLK
• 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: 20226756
• Report Number: 1220246-2024-07657
• Device Sequence Number: 16985413
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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 Expiration Date: 05/31/2026
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 15270826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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