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

Catalog Number AR-1588RT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

Patient demographics (date of birth) was requested but not provided.This is the second of two submissions from the same patient event.The other is 1220246-2016-00288 ((b)(4)).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 devices were requested for evaluation but remained in the patient 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 for the known lot number for the ar-1588rt revealed nothing relevant to this event; no issues were found with the sterilization of this lot.The dhr review could not be performed for the ar-5035tb-09 as the lot number is unknown.Both devices are supplied sterile.Relevant patient health history and preexisting medical conditions were requested but not provided.Based on the information provided, a definitive cause for the post-operative infection for the confirmed organism could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.This is the first complaint of this type for this part/lot number combination.Device remains in patient.

Event Description

It was reported that the 9mm x 35mm cannulated delta tapered bio-interference screw, ar-5035tb-09, along with the acl rt tightrope with titanium, ar-1588rt,was used for an acl procedure on (b)(6) 2016.The surgery was completed successfully with no patient injury.On (b)(6) 2016, the patient came into the facility presenting with fluid on the knee.At this time an arthroscopy with a wash out of the knee was performed.The fluid from the knee was cultured and came back (b)(6).After the procedure, the patient was put on antibiotics, and is doing fine to date.No devices were removed from patient during the second procedure.

• 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: 5773256
• MDR Text Key: 48922047
• Report Number: 1220246-2016-00289
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/22/2016

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: 01/01/2021
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 10028688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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: 24 YR
• Patient Weight: 95