MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG 4.75MM W3 MT BL/CB WH/CB BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72205386
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopic rotator cuff repair procedure, when the healicoil anchor was inserted into the bone hole, it fractured, and the metal tip of the shaft was broken.The fractured anchor and the broken metal tip were removed from the patient.A 3.8 reusable tapered awl was used to make the bone hole.Surgery was completed with a back-up device instead.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed it was not returned with any original packaging.The sutures are still on the device, run through the cannula, and tied at the cleat.A partial deformed and fractured anchor is still on the device.The fractured pieces of anchor were returned.One distal fork of the insertion device has fractured off and was returned.Bio debris is present.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 no 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 properties found the storage requirements and the blended material specifications a clinical review states that undated images of the device were provided for review and confirm the reported breakage for both the anchor and inserter.The photos do not indicate a clinical root cause for the reported event.The device ifu does caution that ¿use of excessive force during insertion can cause failure of the suture anchor or the insertion device.¿ the root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL RG 4.75MM W3 MT BL/CB WH/CB BL
• 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: 21740479
• Report Number: 1219602-2025-00733
• Device Sequence Number: 8735310
• Product Code: MAI
• UDI-Device Identifier: 00885556885352
• UDI-Public: 885556885352
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151105
• 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): 04/30/2025

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: 72205386
• Device Lot Number: 2164380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2024
• 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: 60 YR
• Patient Sex: Male