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

Catalog Number	72290003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during the procedure, the threads of the ultrabutton broke when the graft was being raised.All the pieces were removed, a small incision was made to remove the button betraying the white and green threads of the remaining button.With the help of a guide, the plate was lifted and removed.The procedure was completed using a back-up device.The back up device was used in the originally drilled hole.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.One green flip suture is run through the ultrabutton and shows no defect.The ultrabutton shows use but is not damaged.The blue/white long braid is still run through the ultrabutton and has been cut just above the separation into the adjustable loops.The adjustable loops have been cut on one suture and has a fraying break on the second suture.Bio debris is present.Based on the condition of the product material found during visual inspection, additional material testing is not required.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the material specifications found that a certificate of conformity (c of c) is required with each shipment.Traceability between lot # on c of c and lot # on supporting data is required.Tensile strength compliance must be verified, and parts must be free of loose particulate contamination.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include (1) excessive force (2) contact with a sharp grasper/instrument.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ULTRABUTTON ADJUSTABLE FIXATION DEVICE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21425811
• Report Number: 3006524618-2025-00068
• Device Sequence Number: 20811621
• Product Code: MBI
• UDI-Device Identifier: 00885556613825
• UDI-Public: 885556613825
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72290003
• Device Lot Number: 2147515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 70 KG