MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203380
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference case- (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 procedure, it was noticed that the helicoil anchor was broken when tying the knot.The suture limbs of the broken anchor were cut, and the broken anchor was removed from the patient.The procedure was resumed after a non-significant surgical delay, with a change in the surgical technique by using one helicoil instead of two to repair the supraspinatus as surgeon elected not to implant a replacement anchor and implant a patch, which was secured to the supraspinatus with suture and to the bone with two knotless anchors.A void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in original packaging.The anchor was returned fractured with a partial suture.A major part of the suture and the insertion device were not returned.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.A review of the material specifications found that tensile strength requirements are specified.A material certificate of analysis (coa) is required for raw material.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (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 SA PK 5.5MM W/3 UB-BL CBBL LT
• 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: 24539888
• Report Number: 1219602-2026-00720
• Device Sequence Number: 9027188
• Product Code: MBI
• UDI-Device Identifier: 00885554026313
• UDI-Public: 885554026313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152566
• 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): 04/14/2026

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: 72203380
• Device Lot Number: 2185181
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2025
• 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