MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/26/2025, it was reported by a sales representative via (b)(4) that an ar-1662bc suture anchor threads are stripped.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion and/or improper bone prep.The bone quality of the patient and the information of the instrument used to prepare the bone socket for insertion of the implant were not provided.The dfu for this device, dfu-0087-eo revision 4, gives the following warning: 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.

• Brand Name: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• 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: 22554873
• Report Number: 1220246-2025-02980
• Device Sequence Number: 9785295
• Product Code: MAI
• UDI-Device Identifier: 00888867020566
• UDI-Public: 00888867020566
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: SUTR ANCH SWVLK TENOD BIOCOM 6.25X19.1MM
• Device Catalogue Number: AR-1662BC
• Device Lot Number: 15395460
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown