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

Catalog Number	72205137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/08/2026
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 patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 a rotator cuff repair, after the insertion site was prepared with a 5.5 mm tap and cleared of all debris, when the suture passed through a healicoil knotless anchor's hole, the anchor head broke off.The broken pieces were removed using tweezers.The procedure was resumed, after a non-significant delay, using an equivalent s+n back-up, in an additional bone hole.There was a void left in the patient.Additional anesthesia was not required.No further complications were reported.The patient's status is fine.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 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 inside a opened packaging with the head of the anchor broken off.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 anchor material specification, found that the storage conditions and material requirements are specified for the implant material.Each lot must be accompanied by a material certificate of analysis.The root cause of the reported event 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 an application of unintended inappropriate or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL KNOTLESS PK NST
• 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: 25018495
• Report Number: 1219602-2026-01231
• Device Sequence Number: 13377683
• Product Code: MBI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 885556767337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 72205137
• Device Lot Number: 2180766
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2025
• 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