MAUDE Adverse Event Report: ARTHREX, INC. MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, an arthrex employee reported via email that an ar-9928bck-mis biocomposite knotless achilles speedbridge implant system experienced an issue during use.After anchor insertion, one of the links for the knotless fibertaks was found to be frayed, and the link subsequently broke, preventing the passing of the repair suture through the anchor.The second fibertak anchor functioned as intended, and the procedure was completed without further complication.There was no harm to the patient, and the impact on the case was minimal, resulting in little to no procedural delay.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 17-dec-2025: the occurrence took place during a minimally invasive achilles repair procedure.The original fibertak anchor remained implanted, and the suture that could not be passed through the anchor was trimmed flush.
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.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to improper bone preparation, incorrect surgical technique during the knotless mechanism conversion process, excessive force applied during suture passing/tightening /tensioning, and/or the device coming in contact with another device during use and damage the suture/anchor.

• Brand Name: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
• 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: 23935689
• Report Number: 1220246-2025-05940
• Device Sequence Number: 5611683
• Product Code: HWC
• UDI-Device Identifier: 00888867389533
• UDI-Public: 00888867389533
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• 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): 04/16/2026

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: MIS 3.9MM BC ACHILLES SPDBRG W/ KL DX CC
• Device Catalogue Number: AR-9928BCK-MIS
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown