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

Catalog Number	72205136
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one month after an arthroscopy, the patient showed inflammation in the implantation site of the healicoil knotless rg anchors.An infection was discarded after different tests resulted in negatives.The anchors were removed from the patient, and after that, the wound symptoms improved, and it was healing well; therefore, the surgeon concluded that the implants were rejected.The surgeon thought the healicoil knotless rg anchors caused the reaction.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation and the root cause of the reported event could not be determined due to the limited clinical information provided.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.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 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 clinical review states that one undated photo of the implantation site was provided for review and the site appears to be raised and inflamed consistent with a reaction to something underneath.Per case details, once infection was ruled and the anchors were removed it was noted that the patient was improving.Based on the limited information provided the definitive clinical root cause of the reported adverse event could not be determined.The device instructions for use does note that an allergic reaction or mild inflammatory reaction can occur.¿for healicoil knotless regenesorb suture anchor devices; titanium alloys contain elements that may stimulate allergic hypersensitive responses by the immune system.These elements are titanium, aluminum, and vanadium (ti, al, and v).When sensitivity is anticipated, appropriate preoperative testing should be conducted.¿ no further patient impact is anticipated as the anchors were removed and it was noted that the patient was healing well.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL KNOTLESS RG ST
• 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: 18943518
• Report Number: 1219602-2024-00559
• Device Sequence Number: 12814195
• Product Code: MBI
• UDI-Device Identifier: 00885556767320
• UDI-Public: 885556767320
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K193558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2025
• Device Catalogue Number: 72205136
• Device Lot Number: 51048631
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/29/2024; 05/17/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/06/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male