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

Catalog Number	72203783
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, 2 footprint anchors broke while malleting them into a bone tunnel prepared with 4.0mm drill.The surgeon gave up on putting in a secondary fixation as planned.The tip of the 2nd implant was embedded in the tunnel and was removed with tweezer and suction.The doctor decided to abort the procedure.Bone quality was hard.The insertion site was cleared of all debris.Patient status is recovering.
Event or Problem Description
It was reported that during an arthroscopy, 2 footprint anchors broke while malleting them into a bone tunnel prepared with 4.0mm drill.The surgeon gave up on putting in a secondary fixation as planned.The broken pieces were removed with tweezer and suction, however, the tip of the 2nd implant was embedded in the tunnel.The doctor decided to abort the procedure.Bone quality was hard.Patient status is recovering.
Additional Manufacturer Narrative
H2: correction on h6 (health effect - clinical code and impact code).
Additional Manufacturer Narrative
H3, h6: the shipping information was provided; however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.However, an evaluation of the customer provided images was performed and shows two footprint anchors broke and their boxes.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.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.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 polymer specifications found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.The root cause of the reported event could not be determined since the device was not received for evaluation.Factors that could have contributed to the failure include rough handling or excessive force to the device.No containment or corrective actions are recommended at this time.If the product associated with this event is received 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 ; 5123913905
• MDR Report Key: 17916649
• Report Number: 1219602-2023-01964
• Device Sequence Number: 6782055
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: 00885554029406
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K123579
• 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
• Report Date (Section B): 01/09/2024

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 Catalogue Number: 72203783
• Device Lot Number: 2116001
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 01/03/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/11/2023; 01/09/2024
• Date Device Manufactured: 04/29/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown