MAUDE Adverse Event Report: ARTHREX, INC. DX KNOTLESS FIBERTAK IMPLANT KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX KNOTLESS FIBERTAK IMPLANT KIT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, it was reported by a patient that jumpstart was used during a recent acl surgery.Following the procedure, the patient experienced an extreme topical allergic reaction.No further information was provided.Additional information was received on 15-dec-2025: the patient reported that jumpstart from an ar-8991cp dx knotless fibertak implant kit was applied on (b)(6) 2025, the same day as the procedure.The patient later experienced delayed itching, inflammation, and blistering of the skin.However, the specific allergen involved has not been confirmed.The reaction was treated with a steroid cream.
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.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a patient-specific event, potentially associated with an allergic reaction to the device components.The complaint allegation was confirmed based on the evaluation of the customer-provided image.The findings may be associated with a potential allergic reaction to the device components.

• Brand Name: DX KNOTLESS FIBERTAK IMPLANT KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23921140
• Report Number: 1220246-2025-05881
• Device Sequence Number: 21089994
• Product Code: MBI
• UDI-Device Identifier: 00888867424715
• UDI-Public: 00888867424715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DX KNOTLESS FIBERTAK IMPLANT KIT
• Device Catalogue Number: AR-8991CP
• Device Lot Number: 250205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown