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

Catalog Number AR-1588BTB-J

Device Problems Component Falling (1105); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 02/19/2016

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.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation 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.This is the first complaint of this type for this part/lot combination.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.

Event Description

It was reported that a patient underwent an acl reconstruction procedure on (b)(6) 2016.Approximately one week post-op, patient went to surgeon for follow up visit.Reporter states surgeon said everything looked good but just before patient left office surgeon decided to take an x-ray.X-ray revealed the tightrope button had shifted and dropped down the tunnel behind the kneecap.Revision surgery was performed on (b)(6) 2016.The ar-1588btb-j was explanted.Per facility device was most likely discarded in bio-hazard.

• Brand Name: BTB TIGHTROPE
• 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: 5616915
• MDR Text Key: 43978288
• Report Number: 1220246-2016-00187
• 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,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2016

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 Expiration Date: 08/01/2020
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 300211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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