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

Catalog Number	72205135
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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, while using the correct alignment and hole preparation with the healicoil tap's, three (3) healicoil knotless regenesorb suture anchors failed to engage in the prepared anchor hole.With 2 of the anchors, the tip of the anchor containing the suture was seated in the bottom of the hole and tighten, then a slight tap of the anchor until the 1st thread of the healicoil was engaged in bone was performed, however the healicoil failed to engage in bone.The 3rd anchor split while being advanced into the bone.Upon trying to screw the anchor into bone, the introducer retracted/disconnected from the tip with the sutures which was in the bottom of the prepared hole.2 of the 3 distal tips and sutures were retrieved from the patient with cocker forceps, 1 was not, the surgeon was not concerned about this remaining in the patient due to it being regenesorb.The anchor tip remains seated in the bottom of the prepared hole in bone.The 1st hole was prepared with 4.75mm tap, then every anchor after was prepared using the 5.5mm tap.There are no plans to remove the remaining tip as was seated well with no indication of loosening.2 of the backup devices were inserted into the original prepared holes, and a new hole was prepared for the 3rd device slightly lateral to the hole with the remaining distal tip.The procedure was resumed, after a 20-minute delay, using an equivalent s+n back-up.Additional anesthesia was not required as consequence of the surgical prolongation.No further complications were reported.This report covers 1 healicoil knotless rgnst device from lot 2208236 that remained inside the patient.

• Brand Name: HEALICOIL KNOTLESS RGNST
• 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: 25616709
• Report Number: 1219602-2026-01931
• Device Sequence Number: 10437982
• Product Code: MBI
• UDI-Device Identifier: 00885556767146
• UDI-Public: 885556767146
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: 72205135
• Device Lot Number: 2208236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown