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

Model Number 72290003

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 01/10/2020

Event Type  Injury  

Event Description

It was reported that after an alc procedure with an ultrabutton, the patient developed deep vein thrombosis.The condition was treated with medication (xarelto 15 mg and apixaban) twice per day via oral.The patient recovered successfully.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H2, h3, h6: the reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.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 a isolated issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the potential complications associated with the use of this device.Clinical evaluation was completed and concluded that no relevant clinical information has been provided to perform a thorough medical investigation.Based on the information provided.This patient recovered after treatment with medication (xarelto 15 mg and apixaban) orally twice a day.Since no other harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Factors that could have contributed to the reported event include: (1) potential complications accompanying such implant surgery.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: 10544873
• MDR Text Key: 207283343
• Report Number: 3006524618-2020-00783
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 72290003
• Device Catalogue Number: 72290003
• Device Lot Number: 2032133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 51