MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL KNOTLESS RG ST; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72205136
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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 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.
Event or Problem Description
It was reported that, during an unspecified procedure, the first two threads of two (2) units of the healicoil knotless rg st broke when it was being screwed in.It is unknown how the procedure was performed or if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.An evaluation of the customer provided image was performed and found two healicoil knotless rg st lying on a surface.There are no visual issues.One device has the distal implant still in the inserter.A label in a package next to the devices confirms the device identification information.The breakage cannot be confirmed.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 the storage requirements, packaging details and material characteristics are specified.Factors that can contribute to the reported event include an application of unintended or inappropriate or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for assessment.
Additional Manufacturer Narrative
H10 h3, h6: the reported devices were received for evaluation.An evaluation of the customer provided image was performed and found two healicoil knotless rg st lying on a surface.There are no visual issues.One device has the distal implant still in the inserter.A label in a package next to the devices confirms the device identification information.The breakage cannot be confirmed.A visual evaluation showed two devices were returned in original packaging with the batch number of the complaint on the label.Device one, the distal anchor, distal plug, proximal anchor, and insertion device were returned with no visible defect other than bio debris.Device two's distal anchor and distal plug were not returned.The proximal anchor and insertion device were returned with no visible defect other than bio debris.An assessment of material characteristics found for device one, based on the condition of the product material found during visual inspection, no fracture of the implant could be confirmed.Additional material testing is not required.A material assessment could not be performed for device two due to the part not being returned for evaluation.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 the storage requirements, packaging details and material characteristics are specified.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include an application of unintended or inappropriate or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL KNOTLESS RG ST
• 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: 23677325
• Report Number: 1219602-2025-03041
• Device Sequence Number: 21432932
• Product Code: MAI
• UDI-Device Identifier: 00885556767320
• UDI-Public: 885556767320
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: 72205136
• Device Lot Number: 2185204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 04/29/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 01/21/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2025
• 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