MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH

Catalog Number AR-1588RT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Malaise (2359); Reaction (2414)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed based on the information provided, the most likely cause(s) of this event is a reaction of the patient to the material(s) implanted.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.

Event Description

It was reported by patient's mother, who had originally reported the patient's reaction issues that the patient was seen by new doctors at a new facility for further evaluation.Surgeon decided that the only way to narrow down the causes of the patient's reaction/health issues would be to explant the original arthrex devices and perform multiple biopsies.The devices were explanted on (b)(6) 2016.Reporter states that since the removal the patient's low grade fevers are gone but malaise still exists and patient is still not back to full health.Upon explantation the devices were cultured for infection.Patient's mom reports that the devices were negative for bacteria.Devices explanted were ar-1588rt (mdr report 1220246-00196), ar-1390c (mdr report 1220246-00197), ar-7209 (mdr report 1220246-00198).

• Brand Name: ACL TIGHTROPE RT
• Type of Device: PIN, FIXATION, SMOOTH
• 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: vikram bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5630037
• MDR Text Key: 44343760
• Report Number: 1220246-2016-00196
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/12/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-1588RT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other