MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Impaired Healing (2378)
Date of Event	12/02/2025
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 (b)(6) 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1588rt, acl tightrope® rt, the patient suffers from poor wound healing which leads to bacterial infection.This was detected after an arthroscopic plate fixation surgery for treatment which happened on (b)(6) 2025.The bacterial infection occurred on (b)(6) 2025.The patient was readmitted for treatment.Examination revealed superficial staphylococcus aureus 4+.The original surgery completed, but additional debridement surgery performed to treat the infection.Additional information: treatment included subcutaneous injection of enoxaparin 3800 iu once daily for anticoagulation, wound dressing changes, intravenous infusion of vancomycin 1000 mg every 12 hours for anti-infection, and debridement surgery.By december 16, the wound had healed well.Re-examination showed that inflammatory blood markers had returned to normal, and the patient was discharged.After discharge, the patient needs to continue oral antibiotics for 3 weeks, with linezolid prescribed for ongoing anti-infection treatment.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information available, including the event description, clinical course, and additional field input, the most likely cause of the reported event is a patient-specific, post-surgical wound-related infection.Review of dfu-0147-eo, revision 4, identifies that patient sensitivity and post-operative complications are recognized risks associated with surgical implantation, including: contraindications (section c): foreign body sensitivity and foreign body reactions, including allergic-type reactions.Adverse effects (section d): reported allergic-like reactions to pla materials (plla, pldla), which have occasionally required implant removal.Rare reports of silicone sensitivity.Warnings (section e): postoperative fixation should be considered temporary and requires protection until healing is complete.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device and bone.Patient sensitivity to device materials must be considered prior to implantation.These dfu statements acknowledge that post-surgical infection, wound-healing complications, and patient-specific biological responses are known risks of implantation and may occur.

• Brand Name: ACL TIGHTROPE RT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 24066122
• Report Number: 1220246-2026-00195
• Device Sequence Number: 21399182
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)240617(17)290531(10)15274417
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: ACL TIGHTROPE RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 15274417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown