MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number FIBERTAK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported via the surgical outcome system that a patient had complications of a deep infection, requiring irrigation and debridement, possibly related to an arthrex product.Upon further investigation the following information was obtained: a hip study patient had undergone a hip arthroscopy on (b)(6) 2020 during which an ar-3638 (lot 10396001) arthrex fibertak.Patient began experiencing increasing pain, of the thigh with swelling, day 7 post op.The procedure was a labral repair/ debridement/ osteoplasty.Blood cultures were taken and patient tested positive for gram positive cocci and hip aspirate tested positive for gram positive cocci.At time of report patient has undergone 3 open irrigation and debridements ((b)(6) 2020).During the i&r procedures no products were explanted.The patient's original ar-3638 remains in the patient.To date no additional arthrex products have been implanted.Currently the patient is being treated for the infection with a picc line, iv antibiotics x 6/52.

• Brand Name: FIBERTAK
• Type of Device: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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 ; 8009337001
• MDR Report Key: 9756002
• MDR Text Key: 190805445
• Report Number: 1220246-2020-01723
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867292123
• UDI-Public: 00888867292123
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FIBERTAK
• Device Catalogue Number: AR-3638
• Device Lot Number: 10396001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other