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

Catalog Number	72205601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an acl reconstruction, when the ultrabutton was inserted into a bone hole and adjustable suture was applied tension, the adjustable suture and loop broke.The procedure was completed with a surgical delay of 3 hours using a smith and nephew back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on: b5 & h6 (health effect - impact code).
Event or Problem Description
It was reported that during an acl reconstruction, when the ultrabutton was inserted into a bone hole and adjustable suture was applied tension, the adjustable suture and loop broke.Only the broken loop was removed from the patient's body, the ultra tape was attached of the graft and tied to the button.The procedure was completed with a surgical delay of 3 hours using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.Several pieces of frayed suture were returned with biological debris on them.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.Additional material testing is not required.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications 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.A review of the material specification found that the requirements for the material and the material must comply with provided certificate of conformance.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H2: additional information on: d4 (lot number, expiration date) & h4.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.Several pieces of frayed suture were returned with biological debris on them.Based on the condition of the product material found during visual inspection, it was determined the device damage was caused by the application of improper/excessive force.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 specifications 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.A review of the material specification found that the requirements for the material and the material must comply with provided certificate of conformance.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (1) excessive force.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: this report was inadvertently submitted under manufacturer number ¿3006524618¿, the correct manufacturer number is '1219602¿.

• Brand Name: ULTRABUTTON TIB MED 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): 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: 19060772
• Report Number: 3006524618-2024-00135
• Device Sequence Number: 17816396
• Product Code: MBI
• UDI-Device Identifier: 00885556817216
• UDI-Public: 885556817216
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/30/2024

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: 10/14/2025
• Device Catalogue Number: 72205601
• Device Lot Number: 2103884
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 05/14/2024; 06/17/2024; 08/09/2024; 12/30/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/16/2024; 05/15/2024; 06/17/2024; 08/12/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2022
• 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
• Patient Sex: Unknown