MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERTAPE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 1/18/2023, it was reported by an arthrex employee via email that an ar-1400tb bio-interference screw full thread, an ar-1588t acl tightrope, (3) ar-2324bcc-2 bio composite swivelock, (3) ar-4500 meniscal cinch, (4) ar-7200 fiberwire, and (2) ar-7237 fibertape were all implanted in the patient.This acl and ligament procedure took place on (b)(6) 2023.Patient developed an infection post operative and patient remains admitted to the hospital for treatment.No further information has been provided at this time.Additional information received on 5/15/2024: the patient has not undergone revision surgery, and no further information has been received regarding this incident.
Additional Manufacturer Narrative
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: FIBERTAPE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19533015
• Report Number: 1220246-2024-05732
• Device Sequence Number: 12640740
• Product Code: GAT
• UDI-Device Identifier: 00888867041738
• UDI-Public: 00888867041738
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122374
• 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
• Report Date (Section B): 06/13/2024

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 Expiration Date: 01/31/2026
• Device Model Number: FIBERTAPE
• Device Catalogue Number: AR-7237
• Device Lot Number: 12779424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2021
• 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