MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS PK ST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72205138
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
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 risks with the device itself or with its use 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during shoulder surgery, one healicoil knotless anchor was shredding, with bits of plastic ending up loose in the shoulder joint.It is unknown how the procedure was completed or if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: the reported device was not received for evaluation.However, another device was received.A visual evaluation showed that one unopened device from the same lot as the complaint was returned from the customer for evaluation.The returned packaging and device show no manufacturing abnormalities.A functional evaluation showed that the plug deployed into the anchor with no shredding or flaking observed.The proximal anchor was deployed to the distal anchor with no shredding or flaking observed.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H2: additional information: b5 and h6.
Event or Problem Description
It was reported that during shoulder surgery, one healicoil knotless anchor was shredding, with bits of plastic ending up loose in the shoulder joint.All the material was removed using graspers.The procedure was completed with a similar device.A delay in the surgery occurred; however, the exact duration is unknown.No further complications were reported.

• Brand Name: HEALICOIL KNOTLESS PK ST
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, 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: 24523673
• Report Number: 1219602-2026-00709
• Device Sequence Number: 8430446
• Product Code: MAI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K193558
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 72205138
• Device Lot Number: 2174378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 04/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/24/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2025
• 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