MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS INTBRACE KNEE LIG AUGMENT REPR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMP SYS INTBRACE KNEE LIG AUGMENT REPR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/25/2024
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 (b)(6) 2025, a patient called in an inquiry about the material composition for the ar-1588al-cp2 implant system, ar-1588tnt2 fibertag tightrope ii abs, ar-1588rtt2-ib fibertag® tightrope® ii implant, ar-5511-cp implant system, and ar-3740sp double loaded knotless knee fibertak® anchor.There was no allegation of product deficiency or adverse events reported within this inquiry.On 04/11/2025, it was reported by the patient via phone that she underwent an acl reconstruction on (b)(6) 2024 where the ar-1588al-cp2 implant system, ar-1588tnt2 fibertag tightrope ii abs, ar-1588rtt2-ib fibertag® tightrope® ii implant, ar-5511-cp implant system, and ar-3740sp double loaded knotless knee fibertak® anchor were implanted.The patient began to experience an allergic reaction in (b)(6) 2024 the allergic reaction was confirmed by a physician.The patient had a visible rash, blisters, and oozing out the incisions.Her leg, knee, and ankle were swollen with fluid.It would go and come, this happened until the procedure in (b)(6) 2024 where they went in and cleaned scar tissue.After this procedure, the reaction worsened it spread to the whole right leg.This has been an on and off issue since.The patient was prescribed methylprednisolone 4mg to treat the reaction.
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 a patient-specific event.

• Brand Name: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• 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: 21910984
• Report Number: 1220246-2025-01756
• Device Sequence Number: 17970325
• Product Code: MAI
• UDI-Device Identifier: 00888867109698
• UDI-Public: 00888867109698
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Device Catalogue Number: AR-5511-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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