MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE W/DRV, SYN REPR, TI; WASHER, BOLT NUT

Model Number K-LESS T-ROPE W/DRV, SYN REPR, TI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-8925t syndesmosis tightrope was implanted in a patient and an infection occurred.This was discovered after a tibiofibular ligament repair which was completed successfully.No additional information has been provided.Date of surgery and lot number is unknown.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by an arthrex employee via email that an ar-8925t syndesmosis tightrope was implanted in a patient and an infection occurred.This was discovered after a tibiofibular ligament repair which was completed successfully.No additional information has been provided.Date of surgery and lot number is unknown.

• Brand Name: K-LESS T-ROPE W/DRV, SYN REPR, TI
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13471588
• MDR Text Key: 285217792
• Report Number: 1220246-2022-04410
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: 00888867281608
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: K-LESS T-ROPE W/DRV, SYN REPR, TI
• Device Catalogue Number: AR-8925T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other