MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULR 4.5 PK SUT SL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203783
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, the footprint anchor broke.The procedure was completed using a back-up device.It is unknown if it occurred inside or outside of the patient.It is unknown if there was a delay.No patient complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, 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.It was determined the device did not contribute 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 polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the customer provided image found that the device has not been deployed.The distal end of the anchor is broken, and the plug is visible.The complaint was confirmed, and the root cause was associated with unintended use of the device.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: FOOTPRINT ULR 4.5 PK SUT SL
• 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
• MDR Report Key: 13395659
• Report Number: 1219602-2022-00134
• Device Sequence Number: 11736249
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: 00885554029406
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 08/19/2025
• Device Model Number: 72203783
• Device Catalogue Number: 72203783
• Device Lot Number: 2058976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 04/28/2022
• Date Device Manufactured: 08/19/2020
• 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