MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II ABS; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE II ABS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	03/26/2025
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 3/26/2025, it was reported by a sales representative via email that a wash out procedure was conducted for an infection following a quad autograft acl reconstruction with internal brace and meniscus repair originally performed on (b)(6) 2025.The patient was progressing well in rehabilitation post-surgery until symptoms including fever and knee erythema developed.The surgeon evaluated the patient the following day and confirmed the infection after draining pus-like fluid from the knee.The washout was scheduled urgently.During the procedure, the surgeon collected synovial tissue and fluid for culture analysis and thoroughly cleaned the infected areas, including the incisions on the tibia and femur, which contained infected fluid.The acl hardware was left intact, as the acl itself appeared stable.Cultures were sent for testing, though the specific infectious organism remains unidentified.The initial case involved an ar-1588rtt2-ib fibertag tightrope ii implant for the internal brace, an ar-1588tnt2 fibertag tightrope ii abs, an ar-1588tb-1 tightrope abs button, and an ar-2324pslc peek-swivelock to reconstruct the acl.The meniscus was repaired using products from another manufacturer.No further information was provided.Additional information requested on 4/21/2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 04/21/2025: the infection has been identified as finegoldia magna, the primary cause, with enterobacter cloacae detected only in the enrichment broth.There was no indication that the implants contributed to the infection, and their sterility was not in question.After three washouts, the surgeon determined that removing all implants from the knee was the best course of action.The implants were removed last week, and the patient is now home, recovering with iv and oral antibiotics.
Additional Manufacturer Narrative
Corrected info: b3.
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: FIBERTAG TIGHTROPE II ABS
• 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: 21881730
• Report Number: 1220246-2025-01632
• Device Sequence Number: 8640727
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: 00888867426696
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2025

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: FIBERTAG TIGHTROPE II ABS
• Device Catalogue Number: AR-1588TNT2
• Device Lot Number: 15375805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/22/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/08/2025; 06/09/2025; 09/26/2025
• 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