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

Catalog Number AR-1588RT

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/04/2016

Event Type  Injury  

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 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.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.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.Device was discarded by the facility.

Event Description

It was reported that two acl tightrope rt devices were used for an all inside acl procedure.A graft was seated in the tibial and femoral sockets.The tightropes were inserted and the buttons were flipped on both the tibial and femoral cortices.The tightropes were tensioned and the desired tension was achieved for the graft.The knee of the patient was cycled and the tightropes were re-tensioned.A full flexion and extension was then performed with the patient's leg and the tibial tightrope came loose.An extra incision (surgical intervention) was performed on the lateral side of the knee capsule to remove the graft and broken tightrope.A new tightrope was inserted, and the graft was placed back into the tibial socket to complete the procedure.A total of two tightropes were opened for the procedure, one which came loose and one used to complete the procedure.It is not known which lot number is the one which came loose.Follow-up investigation: it was a femoral tightrope that had come loose, not the tibial tightrope as original reported.The remaining sutures from the femoral tightrope were removed from the acl graft and patient.Surgeon re-threaded the graft on the femoral side with #2 fiberwire and then threaded the fiberwire through the remaining femoral tightrope button.

• Brand Name: ACL TIGHTROPE RT
• 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: 5384784
• MDR Text Key: 36625520
• Report Number: 1220246-2016-00006
• 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,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/06/2016

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: 1189745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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
• Treatment: AR-1588RT, ACL TIGHTROPE RT, LOT 600140.
• Patient Outcome(s): Other