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 Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

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.

Event Description

It was reported by an ent/allergist office that a patient with metal allergy was being treated.Patient has an arthrex ar-8925t, knotless tightrope, in the body.Material composition was requested by the reported and has been provided.No further information was provided at time of initial report but has been requested.

• 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: 11232059
• MDR Text Key: 229102060
• Report Number: 1220246-2021-02505
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867281608
• UDI-Public: 00888867281608
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other