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

Catalog Number	72205137
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy with rotator cuff, after one (1) healicoil knotless suture anchor was inserted, the sutures were locked, and the assembly was secured using the black and orange knobs.Then, the sutures were cut, and the fixation was verified; however, one suture came loose.Subsequently, the remaining sutures were tested, and they began to pull out of the anchor.The anchor was embedded in the patient's bone.An additional bone hole had to be drilled.The procedure was resumed, after a delay greater than 30 min, using an equivalent s+n back-up.Additional anesthesia was required as consequence of the surgical prolongation.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 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.

• 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: 25572932
• Report Number: 1219602-2026-01915
• Device Sequence Number: 14755943
• Product Code: MBI
• UDI-Device Identifier: 00885556767337
• UDI-Public: 885556767337
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 06/22/2026

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: 2200449
• 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: 05/29/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 12/13/2025
• 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 Age: 44 YR
• Patient Sex: Male
• Patient Weight: 80 KG