MAUDE Adverse Event Report: ARTHROCARE CORPORATION ULTRABUTTON TIB MED ADJ FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205601
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924)
Date of Event	11/26/2024
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 product problem associated with a smith+nephew device.The reported problem relates 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 conservatively 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 a revision acl surgery a patient that had previously had an acl surgery by the same surgeon on (b)(6) 2024 where an ultrabutton tib was used for fixation.On the revision surgery it was discovered that the quads graft had become completely separated from the ultrabutton tib construct.The device was explanted.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information in b5, h6: health effect - clinical code h11: h2: corrected information in section g : contact office - manufacturing site.
Event or Problem Description
It was reported that during a revision acl surgery a patient that had previously had an acl surgery by the same surgeon on the (b)(6) 2024 where an ultrabutton tib was used for fixation.On the revision surgery it was discovered that the quads graft had become completely separated from the ultrabutton tib construct.The patient reported instability.The device was explanted.The procedure was completed using a back-up device.The patient slipped and fall on the wet ground.The post operative plan was physical therapy.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation.A clinical review states that an undated photo of the explanted device was provided for review; however, it does not aid in determining the root cause for the reported event.Based on the limited information provided we are currently unable to rule out the reported fall following implantation of the device as a contributing factor to the reported event.Furthermore, it cannot be concluded there was a mal performance of the implant or an implant failure.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 were 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.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include (1) excessive force (2) incorrect loading.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ULTRABUTTON TIB MED ADJ FIXATION DEV
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20973171
• Report Number: 3006524618-2024-00552
• Device Sequence Number: 8462385
• Product Code: MBI
• UDI-Device Identifier: 00885556817216
• UDI-Public: 885556817216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K222971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2025

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 Expiration Date: 10/11/2025
• Device Catalogue Number: 72205601
• Device Lot Number: 2103905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 01/17/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/09/2025; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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: Other; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female