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 Code	Failure to Fire (2610)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2024
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 06/27/2024, it was reported by a sales representative via sems- (b)(4) that an ar-8981bctj-cp implant system and an ar-8982bct dx knotless swivelock knotless mechanism was not firing correctly in these proximal anchors.This occurred during a case both anchors were pulled out and the case was completed using other anchors.
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 of the implant.

• 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: 19764518
• Report Number: 1220246-2024-06800
• Device Sequence Number: 8608938
• Product Code: MAI
• UDI-Device Identifier: 00888867320734
• UDI-Public: 00888867320734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2025

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: 12/31/2025
• Device Model Number: IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT
• Device Catalogue Number: AR-8981BCTJ-CP
• Device Lot Number: 15206667
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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