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

Catalog Number AR-1588BTB

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2014

Event Type  Injury  

Event Description

It was reported that the surgeon put in the quad autograft and passed the needle through the tendon and it appeared bunched up on the side of the tendon.Decided to continue but suture was not set properly and tightrope would not tighten so they pushed the whole graft back up to the tibia.Surgeon removed the button but left the sutures.Completed a tibial tunnel and used a screw to complete case.Acl reconstruction.Delay of case of approximately 1- 1/12 hours.Case completed successfully.

Manufacturer Narrative

Patient demographics (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 part remains in the patient and cannot be returned; therefore.The complainant's event could not be verified.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.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.The most likely cause of this type of event is improper loading of the device, graft preparation and/or tunnel preparation.Per the event description, it is unknown if the tightrope was assembled to the bone block as required per the instructions attached on each device label.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.Part remained in patient.

• Brand Name: BTB TIGHTROPE
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4174177
• MDR Text Key: 16857591
• Report Number: 1220246-2014-00191
• 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: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2014

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: 06/01/2019
• Device Catalogue Number: AR-1588BTB
• Device Lot Number: 1189701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 31 YR