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

Catalog Number AR-1588TN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/10/2014

Event Type  Injury  

Event Description

It was reported that the surgeon used the acl tightrope, ar-1588tn and two dog bone buttons ar-2270 for an acute cc joint reconstruction.The case went well and the cc ( coracoclavicular).Joint was reduced at the conclusion of the case.Five days post-op, the patient noticed his shoulder looked different than immediately after post op.X-rays were taken and the shoulder was no longer reduced.The dog bone buttons appeared to be unmoved and still in contact with the bone, but no longer reducing the joint.Revision date (b)(6) 2014.

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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.Two dog bone buttons and a tight rope were returned.One of the dog bone button was severely bent and broken on one side.There are severe scratches on both buttons.Also, tightrope is broken close to splice area.Broken area appears to be cut.One side of the loop the suture is cinched to the maximum.The ar-1588tn (tightrope) is marketed for acl/pcl indications.The directions for use states arthrex acl tightrope and pcl tightrope are used for fixation of bone to bone or soft tissue to bone and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.This device is specifically used for acl/pcl repair and reconstruction.The most likely cause of this type of event is using devices that are not intended to be used for the specific indication, damage to the device during insertion and/or improper placement and/or non-compliance with the post-op protocol.The product directions for use also state: post-operatively and until healing is complete, the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.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.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• 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: 4147986
• MDR Text Key: 15362728
• Report Number: 1220246-2014-00179
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110123
• 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: 09/12/2014

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: 04/01/2019
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 1189843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: AR-2270, BUTTON, DOG BONE, LOT 899235.
• Patient Outcome(s): Other
• Patient Age: 41 YR