MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202902
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery, one footprint ultra pk suture anchor 5.5 did not press the suture.The procedure was completed with a sn equivalent device.It is unknown if there was surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.Device has been requested for analysis, and an investigation has been opened to evaluate the reported event.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: additional information: h6: health effect - impact code.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the device with the anchor still at the tip with the sutures still on the anchor.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.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include excesive force.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the anchors and sutures on the device.The proximal anchor is in place and partially actuated.There is biological debris on the returned items.A functional assessment of the device found the proximal anchor secures the sutures when fully actuated.An image evaluation was performed and found the device with the anchor still at the tip with the sutures still on the anchor.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include excessive force.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that during a rotator cuff repair surgery, one footprint ultra peek suture anchor 5.5 did not press the suture; after the internal anchors were properly placed, the 3.8 mm bone cone was used to create an opening and then the product was implanted.However, the suture tightening failed.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up on the originally drilled bone hole.No further complications were reported.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5
• 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: 24141728
• Report Number: 1219602-2026-00215
• Device Sequence Number: 9486921
• Product Code: MBI
• UDI-Device Identifier: 03596010650535
• UDI-Public: 3596010650535
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113274
• 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): 04/16/2026

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: 72202902
• Device Lot Number: 2160150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 04/14/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/17/2026; 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2024
• 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: Unknown