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

Catalog Number AR-1588TN

Device Problems Device Operates Differently Than Expected (2913); Physical Property Issue (3008)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 05/28/2017

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.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.Device history record review revealed nothing relevant to this event.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 originally reported that after tightening the tibial side while extending the patient leg, the loop cut into two parts.After finishing the case the threads holding the button ripped and the surgeon was stuck with a short graft for almost two hours trying to cut the femoral button so he can release the graft and repeat the case.The acl reconstruction using all inside technique was performed.After that the surgeon used a different device with part no.: ar-1588rt.Additional information obtained 8 june 2017: the surgeon prepared the graft using an rt tightrope and abs tightrope for the tibia.Graft was a size 11.Both tendons were harvested.Instead of a flip cutter surgeon used and ar-1595t to open the eyelet drill pin for the femur and the tibial cortex was blown out with a drill bit.After passing the graft and shortening the femoral tightrope surgeon began shortening the tibial abs tightrope.All looked fine until surgeon started to probe the graft which was lax.Surgeon went back to the tibial to retighten the tightrope and it was found torn.The graft was short inside the tunnel so surgeon cut the femoral button to release the whole graft which took an hour.The same graft was prepared again and it was fixed with an rt tightrope in the femur and an 11 peek screw in the tibia.Post op testing was fine, new graft looked fine.Additional information obtained 16 june 2017: it wasn't an all inside the surgeon, penetrated the tibial cortex using a drill bit.Neither the tightrope suture material nor the button were left in the patient.

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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed the returned tightrope suture construct to be broken and frayed.No problems found on returned abs tightrope button.The exact root cause was unable to be determined.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 originally reported that after tightening the tibial side while extending the patient leg, the loop cut into two parts.After finishing the case the threads holding the button ripped and the surgeon was stuck with a short graft for almost two hours trying to cut the femoral button so he can release the graft and repeat the case.The acl reconstruction using all inside technique was performed.After that the surgeon used a different device with part no.: ar-1588rt.Additional information obtained 8 june 2017: the surgeon prepared the graft using an rt tightrope and abs tightrope for the tibia.Graft was a size 11.Both tendons were harvested.Instead of a flip cutter surgeon used and ar-1595t to open the eyelet drill pin for the femur and the tibial cortex was blown out with a drill bit.After passing the graft and shortening the femoral tightrope surgeon began shortening the tibial abs tightrope.All looked fine until surgeon started to probe the graft which was lax.Surgeon went back to the tibial to retighten the tightrope and it was found torn.The graft was short inside the tunnel so surgeon cut the femoral button to release the whole graft which took an hour.The same graft was prepared again and it was fixed with an rt tightrope in the femur and an 11 peek screw in the tibia.Post op testing was fine, new graft looked fine.Additional information obtained 16 june 2017: it wasn't an all inside the surgeon, penetrated the tibial cortex using a drill bit.Neither the tightrope suture material nor the button were left in the patient.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• 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: 6692691
• MDR Text Key: 79258568
• Report Number: 1220246-2017-00244
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110123
• 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: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 300472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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