MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (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 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 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 shoulder arthroscopy, after the healicoil anchor was placed in the patient's shoulder, the surgeon noticed a piece of metal at the end of the anchor and the sutures had separated from the anchor.After reviewing the distal tip of the anchor inserter, it was noticed that one side of the metal fork was missing and was left inside the patient.It was believed that the metal tip have cut the plastic tip of the anchor which released the sutures.The procedure was completed with a surgical delay of less than 30 minutes using a smith and nephew back up device in the originally drilled hole.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: part of the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The anchor and sutures were not returned.One of the two forks at the distal end of the insertion device has broken off and was not returned.Bio debris is present.No functional testing can be performed since there is damage hindering the inspection/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 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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).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.

• Brand Name: HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21627770
• Report Number: 1219602-2025-00582
• Device Sequence Number: 8219672
• Product Code: MAI
• UDI-Device Identifier: 00885554031409
• UDI-Public: 885554031409
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123393
• 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
• Report Date (Section B): 04/24/2025

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 Expiration Date: 06/08/2026
• Device Catalogue Number: 72203705
• Device Lot Number: 2121773
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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: 66 YR
• Patient Sex: Male