MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULR 5.5 PK SUT SL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203776
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 b5, e1, e2, g2 and h6: event description, facility address, initial reporter information, report source and impact codes updated.
Event or Problem Description
It was reported that during a rotator cuff suture surgery, one (1) footprint anchor broke while being implanted.All the pieces were removed from the patient.The procedure was performed, after a non-significant delay, using an equivalent s+n back-up.The patient's status is fine.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a rotator cuff suture surgery, one (1) footprint anchor broke while being implanted.The procedure was performed using an equivalent s+n back-up.It is unknown if there was any surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H11 h3, h6.The reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The anchor assembly was returned with the anchor body fractured.The anchor plug has no visible defect.The insertion device and green retention suture have no visible defect.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 no 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 material specification found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (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).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: FOOTPRINT ULR 5.5 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24600281
• Report Number: 1219602-2026-00764
• Device Sequence Number: 8355017
• Product Code: MBI
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/28/2026

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: 72203776
• Device Lot Number: 2137945
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/24/2026
• Initial Report FDA Received Date: 03/14/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2023
• 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