MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202901
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The anchor assembly was returned deformed and fractured.Bio debris is on and in the anchor.Based on the condition of the product material found during visual inspection, 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 material 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.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the reported event include an inadvertent impact event that may have occurred during device transportation, rough shipping and handling, or at the customer site, as well as the application of an unintended, inappropriate, or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that, during a long head of the biceps tendon tenodesis, the surgeon tested the integrity of the footprint ultra peek suture anchor and found that it failed, indicating it had pulled out or otherwise become unusable.The implant was fired when testing, and did not make contact with the patient.The procedure was resumed using an equivalent sn back-up in the originally drilled bone hole.There was a delay of less than 30 minutes.No further complications were reported.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 25068050
• Report Number: 1219602-2026-01319
• Device Sequence Number: 10437765
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 3596010650528
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 72202901
• Device Lot Number: 2149899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2024
• 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: Female