MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TF ULTRA 2 UBRAID AND NDLS 5.5MM TI; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a procedure the twinfix ultrabraid anchor broke.It is unknown how the procedure was finished and if there was a surgical delay.No patient complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: case-(b)(4).H6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the part drawing found that found that no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.It was reported during an unknown procedure the twinfix ultrabraid anchor broke.Based on the limited information provided, it is unknown how the surgery was completed and if there was a surgical delay.However, per case details, the surgeon is not worried as the result of the failure was bone quality.No patient complications were reported.Therefore, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TF ULTRA 2 UBRAID AND NDLS 5.5MM TI
• 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: 13518174
• Report Number: 1219602-2022-00201
• Device Sequence Number: 5298811
• Product Code: MBI
• UDI-Device Identifier: 03596010656131
• UDI-Public: 03596010656131
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K100159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 05/15/2026
• Device Model Number: 72202618
• Device Catalogue Number: 72202618
• Device Lot Number: 2072990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 03/22/2022
• Date Device Manufactured: 05/15/2021
• 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
• Patient Sex: Unknown