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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an knee acl, a footprint ultra was inserted and pushed into a 4mm bone hole drilled into the tibia; the insertion site had been prepared with a 4mm trigen drill short, then when using a mallet to seat the implant, the tip of the implant snapped.The broken tip was removed from the tibia.Surgery resumed after a non-significant delay with a back-up device that was available and opened to complete the implantation of the anchor without any other issues in the same bone hole originally drilled; therefore no voids were left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided image was performed and shows the tip of the implant on the floor.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 polymer specifications found that the raw material strength requirements and storage requirements specified and each lot be must be accompanied by a material certificate of analysis.The root cause of the reported event could not be determined.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.No containment or corrective actions are recommended at this time.

• 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: 17695033
• Report Number: 1219602-2023-01712
• Device Sequence Number: 16794019
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: 00885554029406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 11/09/2023

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 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: 08/17/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 11/09/2023
• 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
• Patient Sex: Unknown