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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
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 27-feb-2026, it was reported by a sales representative via email that the 3.9 mm swivelock anchor from an ar-9928bck-mis mis biocomposite knotless achilles speedbridge implant system had an eyelet that prematurely disengaged from the swivelock driver and did not enter the bone tunnel as expected after insertion.Due to less-than-ideal bone quality, the surgeon elected to use a larger 4.75 mm anchor instead.The 4.75 mm anchor functioned as intended, and there was no adverse effect to the patient.This issue was discovered during a procedure on (b)(6) 2026.Additional information was received on 06-mar-2026: during a mis achilles insertional speedbridge procedure, the 3.9 mm swivelock anchor was removed after the issue occurred.The remaining components of the kit were used.The surgery was completed using an ar-2324bcc biocomposite swivelock c suture anchor.The procedure was delayed by a few minutes, and it is unknown whether additional anesthesia was administered.

• 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: 24640844
• Report Number: 1220246-2026-01531
• Device Sequence Number: 9918767
• Product Code: HWC
• UDI-Device Identifier: 00888867389533
• UDI-Public: (01)00888867389533(11)260120(17)291231(10)15560903
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/08/2026

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
• Device Lot Number: 15560903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• 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