MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72203707
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unspecified arthroscopy, the healicoil rg anchor and tapper were successfully inserted; however, the thread became detached from the implant.The procedure was completed with a s+n back up device.There was a delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: part of the reported device was received for evaluation.A visual inspection revealed it was returned in original packaging with the batch number of the complaint on the label.The anchor was not returned.The sutures were returned with no defect.Bio debris is on the insertion device.A functional evaluation could not performed as this is a single use device and the anchor has already been deployed.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.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 implant fracture due to an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL 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: 18229683
• Report Number: 1219602-2023-02326
• Device Sequence Number: 20388920
• Product Code: MAI
• UDI-Device Identifier: 00885554030860
• UDI-Public: 00885554030860
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151105
• 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
• Report Date (Section B): 02/13/2024

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: 04/13/2026
• Device Catalogue Number: 72203707
• Device Lot Number: 2115991
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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 Sex: Unknown