MAUDE Adverse Event Report: ARTHREX, INC. DX KNOTLESS SWVLK, BC, 4.75 MM, CC FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DX KNOTLESS SWVLK, BC, 4.75 MM, CC FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On, it was reported by a sales representative via email that the screw portion of the anchor from an ar-8980bct dx knotless biocomposite swivelock fell apart during the insertion process.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 2/20/2025: this was discovered during a triceps repair procedure.The eyelet broke off and it was removed.The case was completed using another ar-8980bct dx knotless biocomposite swivelock.The case was delayed forty-five minutes with additional anesthesia.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8980bct serial/batch number (b)(6) was received for investigation.Functional testing was performed by moving/unscrewing/screwing the inner shaft to look for any resistance.No issues were found.Upon visual evaluation, it was noted that the screw/bio threads were warped and completely damaged.The eyelet is inside the shaft broken.The device sutures were broken, as only one was noted on the device shaft.The most likely cause of the reported failure is user error, such as improper bone preparation, applying excessive force during insertion, or leveraging/prying the device.

• Brand Name: DX KNOTLESS SWVLK, BC, 4.75 MM, CC FT
• 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: 21333317
• Report Number: 1220246-2025-00296
• Device Sequence Number: 15486034
• Product Code: MAI
• UDI-Device Identifier: 00888867319882
• UDI-Public: (01)00888867319882(11)230203(17)250131(10)15052605
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Followup
• Report Date (Section B): 04/15/2025

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: 01/31/2025
• Device Model Number: DX KNOTLESS SWVLK, BC, 4.75 MM, CC FT
• Device Catalogue Number: AR-8980BCT
• Device Lot Number: 15052605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: Not provided; 03/28/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/19/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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