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

Catalog Number AR-1588RT

Device Problems Break (1069); Extrusion (2934); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 05/07/2015

Event Type  Injury  

Event Description

It was reported that the event happened during "acl reconstruction" surgery.After the surgeon finished the fixation of the tightrope, he heard a click sound and the graft become lax, he checked the femoral attachment and found the loop of the tightrope already gone.Follow-up investigation: during the graft fixation from the tibial side with the bio-composite interference screw, a click sound was heard and suddenly the tension of the graft got lost 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 was out from its sheath.No piece broke inside the patient.The surgery was completed by fixing the graft with interference screws from femoral and tibial sides.

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.

• 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: 4865233
• MDR Text Key: 5863051
• Report Number: 1220246-2015-00165
• 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
• Report Date: 06/01/2015

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: 09/01/2019
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 1284813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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