MAUDE Adverse Event Report: ARTHROCARE CORP. ULTRABUTTON ADJUSTABLE FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72290003

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 10/17/2017

Event Type  Injury  

Event Description

It was reported that post-operatively, the button was not seated against the femoral cortex and instead was found resting high in the soft tissue 5 -10 mm.Revision surgery was performed to remove the implant.

Manufacturer Narrative

The reported ultrabutton fixation device, intended for use in treatment, was not returned for evaluation.Attempts were made to retrieve the product and product has yet to be received.If the product is received at a later date, this complaint will get re opened and product evaluation processed.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and customer complaint cannot be confirmed.From the information provided, the button was not seated against the femoral cortex and instead was found resting high in the soft tissue 5 -10 mm.An exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) bone quality or (2) incomplete insertion.Insufficient quality or quantity of bone, inadequate bone stock or comminuted bone surfaces could compromise secure fixation of the implant.Also, incomplete insertion or poor bone quality may result in implant pullout.An exact root cause cannot be determined with confidence as no product was received for evaluation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ULTRABUTTON ADJUSTABLE FIXATION DEVICE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon; austin, TX 78735
• MDR Report Key: 6998536
• MDR Text Key: 90935024
• Report Number: 3006524618-2017-00341
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72290003
• Device Lot Number: 1159129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention