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

Catalog Number 72290003

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Date 06/06/2017

Event Type  Injury  

Event Description

It was reported that during acl reconstruction surgery using the ultrabutton, the flipping thread got cut off and there was laceration to the graft.No other complications were reported.

Manufacturer Narrative

The reported ultrabutton device, intended for use in treatment, was not returned for evaluation.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 customers complaint cannot be confirmed.From the information provided, flipping thread got cut off and there was laceration to the graft.An exact root cause cannot be determined without evaluation of the device; however, factors that could have contributed to the reported event include: (1) sharp edges.Sharp edges on the button can result in damage to the flipping thread and laceration to the graft.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: 6675773
• MDR Text Key: 78654041
• Report Number: 3006524618-2017-00151
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K153186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 72290003
• Device Lot Number: 2001748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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): Other