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 Problem Fibrosis (3167)

Event Date 12/09/2016

Event Type  Injury  

Event Description

It was reported that after a left knee extra-capsular repair and mpfl reconstruction with q-fix, the patient had left knee arthrofibrosis due to post-operative stiffness.The event was treated with surgery 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 h3, 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 and device record review could not be conducted.Although requested, no x-ray images or information on the patient compliance with post-operative instructions were provided for review.Clinical/medical evaluation was completed and concluded that without the requested clinical information a thorough medical investigation cannot be rendered.The reported issue has been documented as resolved due to the surgical intervention.Should any additional clinical information be provided this complaint will be re-evaluated.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.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: (1) 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: 10103924
• MDR Text Key: 193032930
• Report Number: 3006524618-2020-00318
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K133727
• 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: 07/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25-2800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 51