MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT
Medical Device Problem Codes	Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
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 5/9/2025, a sales representative reported via email an issue with the ar-8981bctj-cp dx swivelock implant system.The knotless 4.75mm swivelock from the kit failed to hold tension on the tendon after the working stitch was passed through the knotless shuttling mechanism.The working stitch did not maintain tension and continued to slide.As a result, instead of completing a knotless repair, the sutures on the anchor were used to tie the tendon down to the bone, resulting in a knotted repair.This issue was discovered during a kidner procedure involving advancement of the posterior tibial tendon on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 6/2/2025: during the procedure, the implant remained securely inside the patient's bone, and no fragments were left inside the patient.The case experienced a fifteen-minute delay due to the malfunction; however, the procedure was successfully completed.No additional anesthesia was required beyond the original plan.
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 can be misuse due to misaligned insertion or prying/leveraging the device during insertion.

• Brand Name: IMPLANT SYS, DX KL SL, 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: 22123936
• Report Number: 1220246-2025-02324
• Device Sequence Number: 20704051
• Product Code: MAI
• UDI-Device Identifier: 00888867320734
• UDI-Public: (01)00888867320734(11)240919(17)260731(10)15319901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/13/2025

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: 07/31/2026
• Device Model Number: IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT
• Device Catalogue Number: AR-8981BCTJ-CP
• Device Lot Number: 15319901
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 10/08/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/23/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown