MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, BUTTON, 8 X 12 MM; PIN, FIXATION, SMOOTH

Catalog Number AR-1588TB

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Sepsis (2067)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

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 device was not returned for evaluation but remains 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.The most likely cause of this type of event is an adverse reaction of the patient to the material(s) implanted.Product directions for use warns of adverse effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to device materials must be considered prior to implantation.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 reported that patient had a left knee acl with hamstring autograft procedure on (b)(6) 2015.Patient had an uneventful surgery with no known breaks in techniques.Bone quality good.Patient developed septic arthritis / effusion four weeks from surgery date.All cultures on trays were negative for biologicals.Patient cultures have been negative to date.

• Brand Name: TIGHTROPE ABS, BUTTON, 8 X 12 MM
• 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: 5213130
• MDR Text Key: 30837120
• Report Number: 1220246-2015-00302
• 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: Other
• Type of Report: Initial
• Report Date: 10/19/2015

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: 02/01/2020
• Device Catalogue Number: AR-1588TB
• Device Lot Number: 1349551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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
• Patient Age: 20 YR
• Patient Weight: 113