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

Model Number FIBERTAG TIGHTROPE II WITH INTERNALBRACE

Device Problem Misassembled (1398)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, it was reported by a sales representative via email that an ar-1588rtt2-ib fibertag tightrope ii implant for the internalbrace technique was assembled incorrectly, and white strands would not shorten.Had to cut it off the graft.This was discovered during a procedure.The case was completed with another ar-1588rtt2-ib with no patient harm.Additional information received on 2/28/2024: this was discovered during a quad aclr procedure.The case was delayed about ten minutes; however, additional anesthesia was unnecessary.The patient did not suffer any negative effects on or after the procedure.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• Type of Device: 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: 18890052
• MDR Text Key: 337533603
• Report Number: 1220246-2024-01439
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867426689
• UDI-Public: 00888867426689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAG TIGHTROPE II WITH INTERNALBRACE
• Device Catalogue Number: AR-1588RTT2-IB
• Device Lot Number: 15175689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1