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

Model Number 72290003

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during a acl procedure, after the ultrabutton flipped on the lateral cortex of the femur, when the loop was being reduced, it broke midway.All pieces were removed from the patient with suction & graspers.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.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, intended for use in treatment, was not returned for evaluation.There was a relationship found between the device and the reported incident, as an image of the device was submitted by the customer.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.Clinical evaluation was completed and concluded that per e-mail communication, the broken pieces were removed from the patient and a backup device was used to complete the procedure.No delay or patient injuries are being reported.Since no harm is being alleged, no further clinical assessment is warranted.A visual investigation of the customer submitted image shows an used ultrabutton with the button and broken sutures.Visual inspection and functional testing could not be performed since the device was not returned for evaluation; however, the complaint was confirmed as the submitted image provide sufficient evidence to confirm.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: possible incorrect flipping or reduction or incorrect tunnel preparation.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 10873068
• MDR Text Key: 217289075
• Report Number: 3006524618-2020-01012
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885556613825
• UDI-Public: 00885556613825
• Combination Product (y/n): N
• PMA/PMN Number: K153186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: 72290003
• Device Catalogue Number: 72290003
• Device Lot Number: 2026965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention