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

Catalog Number AR-1588RT

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2018

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.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that all steps were followed adequately after applying final tensioning while using the ar-1588rt acl tight rope rt tightrope the graft loosen about 15mm.Tried to tighten again and it did the same thing.Took an abs tibial button and placed it on the outside cortex of the femur and tied a knot to secure the graft.The procedure was completed.The product remains in the patient.Procedure: acl reconstruction.The quality of the bone was good.Representative was present during the procedure: patient: (b)(6) male.

• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7540113
• MDR Text Key: 109117020
• Report Number: 1220246-2018-00197
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019553
• UDI-Public: 00888867019553
• 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: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/24/2018

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: 12/01/2022
• Device Catalogue Number: AR-1588RT
• Device Lot Number: F182667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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
• Patient Age: 36 YR