MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC KNOTLESS SWIVELOCK
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/7/2024, it was reported by a sales representative via email that an ar-2324kbcc biocomposite knotless swivelock anchor would not engage with the patient's bone during insertion.The case was completed using another 324kbcc biocomposite knotless swivelock.This was discovered during an rcr procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 10/16/2024: the case was not delayed, as a second anchor was opened right away to continue the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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 a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 20456331
• Report Number: 1220246-2024-08136
• Device Sequence Number: 8724479
• Product Code: MAI
• UDI-Device Identifier: 00888867351288
• UDI-Public: (01)00888867351288(11)240731(17)280630(10)15295350
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 15295350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided; 06/11/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/31/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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