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

Catalog Number AR-1588RT

Device Problems Break (1069); Detachment Of Device Component (1104); Device Slipped (1584); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 06/07/2015

Event Type  Injury  

Event Description

It was reported that this event occurred during an acl reconstruction surgery.During the knee cycling, a click sound was heard and suddenly the tension of the graft got loose and while checking it the surgeon found the graft coming out from the femoral socket and the tightrope become loose.He brought it out from the femoral side and found that the loop was already broken and got out from its sheath.The surgeon fixed the graft by interference screws from femoral and tibial sides.It was finished well follow-up investigation: after the failure happened, the surgeon removed the tightrope from the graft and used /put interference screws, so the same tightropes were re-used.

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.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.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.Part remained in patient.

Manufacturer Narrative

This is a follow-up submission to reflect details from the device evaluation.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.Device history record review revealed nothing relevant to this event.Complaint evaluation revealed that the suture broke at the center where button sat, and the other end broke at the proximal surface.Both ends of the sheath are frayed at the top portion where button sat.No other damage or abnormalities were observed.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 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 this event occurred during an acl reconstruction surgery.During the knee cycling, a click sound was heard and suddenly the tension of the graft got loose and while checking it the surgeon found the graft coming out from the femoral socket and the tightrope become loose.He brought it out from the femoral side and found that the loop was already broken and got out from its sheath.The surgeon fixed the graft by interference screws from femoral and tibial sides.It was finished well follow-up investigation: after the failure happened, the surgeon removed the tightrope from the graft and used /put interference screws, so the same tightropes were re-used.

• 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: 4873853
• MDR Text Key: 21185691
• Report Number: 1220246-2015-00172
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

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: 03/01/2020
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 1308508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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