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 Bacterial Infection (1735); Fever (1858); Pain (1994); Swelling (2091)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

Patient demographics (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.The device was requested for evaluation but part remains in the patient and cannot be returned 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 revealed nothing relevant to this event.This device is supplied sterile.Review of the lot sterilization records revealed no discrepancies.The organism identified in the culture is an anaerobe bacteria commonly found in sebaceous glands and follicles.Nosocomial cross-contamination is most likely the cause of the reported infection.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.

Event Description

It was reported that the patient underwent a right acl reconstruction on (b)(6) 2015.Approximately six weeks post-op, the patient developed symptoms of pain, swelling and low grade fever.Septic arthritis was suspected.On (b)(6) 2015 patient underwent incision and drainage, synovectomy to treat his condition.Cultures were positive for propionibacterium.

• 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: 5229090
• MDR Text Key: 31338691
• Report Number: 1220246-2015-00312
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/26/2015

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: 10/26/2015
• Initial Date FDA Received: 11/17/2015
• 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
• Treatment: AR-1588RT-J, ACL TIGHTROPE SUTURE, LOT 1189810
• Patient Outcome(s): Other
• Patient Age: 19 YR