MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; PIN, FIXATION, SMOOTH

Catalog Number AR-1588TB-1

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Fibrosis (3167)

Event Date 03/04/2015

Event Type  Injury  

Event Description

It was reported that an injured worker had a quadriceps tendon acl reconstruction- failure of the tibial fixation button with proximal migration into the tibial tunnel.Follow-up investigation: medical records provided.Original surgery was on (b)(6) 2015.During post-op visit on (b)(6) 2015, an x-ray revealed that the right knee failed tibial fixation from acl reconstruction of (b)(6) 2015.Proximal migration of the tibial fixation button into the tibial tunnel.Femoral fixation was intact.Revision surgery was performed (b)(6) 2015.During revision, surgeon was able to slip a stitch through the white of the tight-rope with a suture slider wire and as he pulled back on the graft he was able to disengage the toggle-loc on the femoral cortex.The graft was taken out.The button was removed from the tibial side of the fixation.A new pull suture was placed on the toggleloc.The toggleloc was then pulled and re-flipped on the femur.Then a 6.5 mm cannulated screw and washer was used on the tibia to tie the graft.The graft was firmly tied down with two #5 fiberwires with the knee in full extension.Patient's lochman's test was now negative and the knee was cycled and found to have excellent fixation.There was fibrinous material in the supra-patellar region from bleeding and this was removed and incision was closed.

Event Description

It was originally reported that an injured worker had a quadriceps tendon acl reconstruction- failure of the tibial fixation button with proximal migration into the tibial tunnel.Follow-up investigation: during a post-op visit on (b)(6) 2015, an x-ray revealed that the right knee failed the tibial fixation.There was a proximal migration of the tibial fixation button into the tibial tunnel.Femoral fixation was intact.A revision surgery was performed on (b)(6) 2015.During the revision, her anteromedial portal was opened and the graft was confirmed to be loose intra-articularly.The tibial tunnel was then exposed after recreating the tibial incision and extending this 0.5cm to make this over 2cm.The surgeon was able to slip a stitch through the white of the tightrope with a suture slider wire, and as he pulled back on the graft, he was able to disengage the toggleloc on the femoral cortex, and the graft was taken out.The button was removed from the tibial side of the fixation.A new pull suture was placed on the toggleloc.The toggleloc was then pulled and re-flipped on the femur, and then a 6.5 mm cannulated screw and washer were used on the tibia to tie the graft.The graft was firmly tied down with two #5 fiberwires with the knee in full extension.The patient's lachman's now was negative, and at this point, the knee was cycled and found to have excellent fixation.There was fibrinous material in the suprapatellar region from bleeding and this was removed.At this point, irrigation was used on the incisions and they were closed in layers with 0 vicryl deep, 3-0 vicryl superficial, and monocryl for skin.Also, the original button was removed and discarded.

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.The device was requested for evaluation but part remains in the patient and cannot be returned therefore the complainant's event could not be verified.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.Unknown device disposition.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This is a follow-up submission to update the event details and the narrative data.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.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.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• 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: 4799796
• MDR Text Key: 5918862
• Report Number: 1220246-2015-00139
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2015

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: 10/01/2019
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 1216919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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-1588TN, TIGHTROPE, LOT 1282802; AR-1588TN, TIGHTROPE, LOT 1282802; AR-1592, RETROBUTTON, LOT 698685.; AR-7264, #2 FIBERLOOP, LOT 1441138; AR-7264, #2 FIBERLOOP, LOT 1441138; AR-1592, RETROBUTTON, LOT 698685.
• Patient Outcome(s): Other