MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN Q-FIX SOFT SUTURE ANCHOR DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 25-2800

Device Problem Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Fibrosis (3167)

Event Date 11/09/2016

Event Type  Injury  

Event Description

It was reported that after surgery with q-fix, the patient had arthrofibrosis on the left knee due to post-operative stiffness.The event was treated with manipulation under anesthesia, as the patient continued to have a range of motion problems, a second manipulation under anesthesia was performed and the patient recovered.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h6.The device reported, used in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established.No product identification information was provided, thus a manufacturing record and complaint history review could not be conducted.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Clinical evaluation was completed and concluded that this complaint from the united states and the q fix clinical study reports that a patient developed ¿arthrofibrosis¿.The subject continued to have range of motion problems after the first manipulation under anesthesia.A second manipulation under anesthesia was performed and the patient recovered.The clinical study report forms were provided for review but did not reveal a root cause for the arthrofibrosis.However this is a recognized complication of the surgery.Smith and nephew has not received adequate materials (the operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: potential complications accompanying such implant surgery.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: UNKN Q-FIX SOFT SUTURE ANCHOR DEV
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10103931
• MDR Text Key: 193034236
• Report Number: 3006524618-2020-00321
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25-2800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 60