MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRABUTTON TIB LG ADJ FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72205602
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Laceration(s) (1946); Perforation (2001)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
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 a quad st acl reconstruction surgery, the loop of the ultrabutton tib medium adjustable fixation did not reduce on the first attempt with the device, the surgeon experienced extreme stiffness, making it difficult to move, resulting in the button tearing off the graft, which compromised the ultrabutton quad adjustable fixation femoral attachment, it was unable to be used on the remaining graft.On the second attempt, with the second ultrabutton tib medium adjustable fixation, the tibial button was tested outside the knee joint, but it would not reduce despite full-force pulling, different angles, and multiple reduction attempts.When a third device was opened, a large ultrabutton tib adjustable fixation device, it was found that the blue suture went through the reducing sutures, therefore, the surgeon removed and added their own suture to be able to reduce that one.The procedure was completed using a quad button and tib button large backup devices.The surgery took 6 and a half hours, therefore, there was a delay greater than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A clinical review states the ultrabutton quad, bb and tib adjustable fixation devices instructions for use details the training requirements, prep & steps to facilitate fixation along w/warnings, & precautions including to inspect the device to ensure it is not damaged prior to use.An user technique/procedural variance cannot be ruled out as a possible contributing factor to the reported events.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
This report was inadvertently submitted under manufacturer report number 3006524618, correct manufacturer report number is (b)(4).

• Brand Name: ULTRABUTTON TIB LG ADJ FIXATION DEV
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• 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: 20824722
• Report Number: 3006524618-2024-00519
• Device Sequence Number: 8928339
• Product Code: MBI
• UDI-Device Identifier: 00885556817223
• UDI-Public: 885556817223
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K222971
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Catalogue Number: 72205602
• Device Lot Number: 2109285
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/27/2024; Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 72205443 LOT NUMBER: 2143896; PN: 72205601 LOT NUMBER: 2103884; PN: 72205601 LOT NUMBER: 2103923
• Patient Age: 35 YR
• Patient Sex: Male