MAUDE Adverse Event Report: ARTHREX, INC. DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 8/11/2025, it was reported by a health care provider that a patient developed eczematous dermatitis following ankle surgery in which an ar-1678-cp internalbrace ligament augmentation repair implant system, an ar-8990st-2 fibertak dx, and an ar-8990st fibertak dx were implanted.The patient has a documented contact allergy to the preservative 2-bromo-2-nitropropane-1,3-diol (bronopol).No further information was provided.
Additional Manufacturer Narrative
Correction: h1 to n/a.Upon secondary review, it was determined that the event is not reportable.The allegation of an allergic reaction to 2-bromo-2-nitropropane-1,3-diol (bronopol) leading to dermatitis was made.Upon investigation, it was determined that arthrex processes and final cleaning operations do not contain a bromo functional cleaning material.An fda mdr is not required for this event.There was no allegation of a malfunction of the device or that it did not meet specifications, nor was there an allegation that the device caused or contributed to an adverse event.Thus, the event is considered not reportable.

• Brand Name: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• 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: 22902288
• Report Number: 1220246-2025-03655
• Device Sequence Number: 20833258
• Product Code: MBI
• UDI-Device Identifier: 00888867377370
• UDI-Public: (01)00888867377370(11)220429(17)270331(10)14955358
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Device Catalogue Number: AR-8990ST-2
• Device Lot Number: 14955358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown