MAUDE Adverse Event Report: ARTHREX TIGHTROPE ABS BUTTON ARTHREX INC.

Device Problem Product Quality Problem (1506)

Patient Problems Fever (1858); Swelling (2091); Post Operative Wound Infection (2446)

Event Date 08/17/2015

Event Type  Injury  

Event Description

A (b)(6) male underwent right acl reconstruction on (b)(6) 2015.Approximately six weeks later patient developed symptoms of pain, swelling, and low grade fever - suspected septic arthritis.On (b)(6) 2015 patient underwent incision and drainage; synovectomy to treat condition.Cultures were positive for propionibacterium acnes.

• Brand Name: TIGHTROPE ABS BUTTON ARTHREX INC.
• Type of Device: TIGHTROPE ABS BUTTON
• Manufacturer (Section D): ARTHREX; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 5430848
• MDR Text Key: 38143052
• Report Number: 5430848
• Device Sequence Number: 2
• Product Code: HTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 19 YR