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

Catalog Number AR-1588RT-J

Device Problems Material Rupture (1546); Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/21/2015

Event Type  Injury  

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 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.This type of event is typically caused by nicking the suture with another instrument, fraying from sharp edges of the bone tunnel and/or applying excessive force when shortening the suture strands.The directions for use for the device states: "excessive force on the shortening suture strands may break the strands and impair ability to fully seat the implant".This is the second 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.Facility will not release the device.

Event Description

It was reported that there was an acl reconstruction operation.As surgeon stretched patient's leg, he heard a sound and he took an mri and ct.The mri and ct showed that the graft became loose.He decided to do a second surgery and he found that tightrope was ruptured.The second surgery was successful.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, 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.Complaint confirmed.The evaluation revealed that the returned splice loop strand's tip appeared to have been cut on one returned suture and frayed on the other.Two buttons were returned.New braided uhmwpe white suture was used to test the buttons for sharp edges and breakage.One button had no visual anomalies, did not break the sutures and no sharp edges were observed.The other button received was severely damaged.Scratches/dents/nicks were present which appeared to have been caused by user mechanical damage, such as hitting the device with another device, causing the suture to fray during function testing.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 there was an acl reconstruction operation.As surgeon stretched patient's leg, he heard a sound and he took an mri and ct.The mri and ct showed that the graft became loose.He decided to do a second surgery and he found that tightrope was ruptured.The second surgery was successful.

• Brand Name: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• 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: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 5038769
• MDR Text Key: 24407851
• Report Number: 1220246-2015-00223
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 11/23/2015

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: 11/01/2019
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 1189809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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