MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS; WASHER, BOLT, NUT

Model Number KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

On 2/12/2024, it was reported by an arthrex subsidiary employee via email that an ar-8926ss knotless tightrope syndesmosis repair implant broke directly from the button without friction in the bone.This was discovered during a procedure on (b)(6) 2024.No additional information provided.Additional information requested.Additional information provided 2/21/24: the date of the procedure was (b)(6) 2024.The procedure performed was an ankle rafi with dex system, plus sisndemosys reduction.Each button broke when starting the one-by-one reduction of the sutures.When the sutures broke, each button came out on each side of the ankle (medial and lateral).There was a 40-minute delay and additional anesthesia was administered.The case was completed by reassembling the system with independent sutures (fiberwire 5).

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Type of Device: WASHER, BOLT, NUT
• 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: 18807503
• MDR Text Key: 336561643
• Report Number: 1220246-2024-01207
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Device Catalogue Number: AR-8926SS
• Device Lot Number: 27663
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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