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

Model Number	KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
Medical Device Problem Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via phone that an ar-3653sp knotless 2.6 fibertak rc soft anchor had an issue.During a rotator cuff repair procedure on (b)(6) 2025, when the surgeon was working through the posterior cannula and had inserted the anchor, it did not seat properly.When pulling on the sutures, the anchor came out of the patient's body in one piece.Nothing broke inside the patient, and everything was removed from the patient.Another ar-3653sp knotless 2.6 fibertak rc soft anchor with a different unknown lot number was used to complete the procedure successfully with no harm to the patient.The complaint device was discarded, and no pictures were taken.There was a case delay of a couple of minutes, and additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation and incorrect surgical technique during device application.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: KL FBTK RC, (WH/BLK)TT & (BLU)#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: 21334380
• Report Number: 1220246-2025-00307
• Device Sequence Number: 14415229
• Product Code: MBI
• UDI-Device Identifier: 00888867370043
• UDI-Public: (01)00888867370043(11)240305(17)290228(10)15215806
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/10/2025

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 Model Number: KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
• Device Catalogue Number: AR-3653SP
• Device Lot Number: 15215806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown