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

Catalog Number	72205138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 a procedure, a healicoil knotless metal self-tapping tip broke off inside the humeral head.The full anchor was successfully removed.It is unknown how the procedure was performed or if there was a surgical delay.No further complications were reported.
Event or Problem Description
It was reported that, during a procedure, a healicoil knotless metal self-tapping tip broke off inside the humeral head.The full anchor was successfully removed using a grasper.The procedure was resumed without any delay, using an equivalent s+n back up device in a more medial position than the first anchor.There was no void left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: additional information on: b4 (describe event or problem), h6 (health effect - clinical code / health effect - impact code).Corrected information on: e1, e2, e3, g2.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found a healicoil knotless device lying on a drape with the distal tip completely detached.The distal tip is attached to the suture near the device.The proximal anchor is not fully contained within the outer tip of the shaft.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 assembly process found that a final visual inspection shall be performed prior to packaging.The device shall be visually examined to identify any damage to both proximal and distal implants.It is necessary to confirm that the anchors are free of burrs, cracks, or other surface defects.Likewise, it is necessary to verify that the anchors are loaded in the correct orientation in accordance with applicable specifications.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 (excessive force upon insertion, off-axial insertion, not maintaining inserter alignment throughout insertion to ensure implant integrity).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL KNOTLESS PK 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: 23677097
• Report Number: 1219602-2025-03037
• Device Sequence Number: 21433044
• Product Code: MAI
• UDI-Device Identifier: 00885556767351
• UDI-Public: 885556767351
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2026

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: 72205138
• Device Lot Number: 2185210
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 01/06/2026
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2025
• 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