MAUDE Adverse Event Report: ARTHREX, INC. KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS; ARTHROSCOPIC ACCESSORIES

Model Number	KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/1/2022, it was reported by a sales representative via email that an ar-3653ttsp knotless fibertak dr would not set, even after multiple attempts from the surgeon to deployed the anchor.This was discovered during a rcr procedure on (b)(6) 2022.Additional information received on 2/2/2022: the case was completed by the doctor using (2) 2324kbcct 4.75 swivelock anchors.Nothing broke inside the patient and case was completed successfully without further issues.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical forces.

• Brand Name: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19247077
• Report Number: 1220246-2024-02788
• Device Sequence Number: 17789588
• Product Code: MBI
• UDI-Device Identifier: 00888867370081
• UDI-Public: 00888867370081
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 08/31/2026
• Device Model Number: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Device Catalogue Number: AR-3653TTSP
• Device Lot Number: 14217544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown