MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 5.5MM W/2 UB-BL, CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203379
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks 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 conservatively submitting this report in accordance with applicable regulations.If additional 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, when the healicoil anchor was going to be implanted in the space prepared with the initiator, the thread steps fractured, a portion of the implant fragmented inside the patient and it was successfully removed with a shaver.The procedure was completed without surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.Patient is stable.
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 the anchor on the insertion device.Some of threads of the anchor have fractured.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 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 (use of excessive force during insertion).Based on this investigation, there is no evidence to suggest a design, material, or manufacturing issue.Therefore, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The sutures are still on the device, run through the cannula, and tied at the cleat.The anchor is still on the device.The distal threads of the anchor are fractured.The fractured threads were not 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 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 (use of excessive force during insertion).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: HEALICOIL SA PK 5.5MM W/2 UB-BL, CBRD BL
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21260975
• Report Number: 1219602-2025-00205
• Device Sequence Number: 18526184
• Product Code: MBI
• UDI-Device Identifier: 00885554026306
• UDI-Public: 885554026306
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K113294
• 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,Followup
• Report Date (Section B): 07/28/2025

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: 72203379
• Device Lot Number: 2159892
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 07/24/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/06/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2024
• 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: A
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG