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

Catalog Number AR-1588RT

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported that during an acl reconstruction, the tightrope broke at the suture loop/top of the button contact.This occurred during final tightening.The button remained in the patient between the bone and tissues.A femoral notch screw was inserted since there was a loss of tension and the case was completed.Follow-up: only one tightrope and one screw were used for this procedure.The surgeon pulled the graft into the socket and began the final femoral tensioning of the tightrope and the suture gave way, she then inserted a bio composite interference screw to hold the graft in place.The button remained in the patient between the bone and tissues.The case was completed, a screw was inserted to hold the graft in place.

Manufacturer Narrative

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 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.This type of event is typically caused by applying excessive force on the shortening strands, nicking the suture with another instrument and/or fraying from sharp edge of the bone tunnel.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.Per customer device will not be returned.

• Brand Name: ACL TIGHTROPE RT
• 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: 4296417
• MDR Text Key: 20749261
• Report Number: 1220246-2014-00244
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/12/2014

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-1588RT
• Device Lot Number: 1189779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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