MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM PEEK KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	5.5MM PEEK KNOTLESS SWIVELOCK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
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 (b)(6) 2025, it was reported by a sales representative via email that two ar-2323kpslc peek knotless swivelock failed during use.The first swivelock failure occurred when the locking mechanism did not hold, compromising the functionality of the device.The second swivelock failure involved an issue with the suture on the loop, where it bunched up and was unable to pass through the anchor as intended.This was discovered during an rcr procedure on (b)(6) 2025.Additional information requested on 4/19/2025.
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, including improper bone preparation and misalignment of the insertion.The complaint allegation was not confirmed as the device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: 5.5MM PEEK 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: 21935097
• Report Number: 1220246-2025-01796
• Device Sequence Number: 5342886
• Product Code: MAI
• UDI-Device Identifier: 00888867351349
• UDI-Public: (01)00888867351349(11)250203(17)300131(10)15382454
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 09/26/2025

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: 5.5MM PEEK KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2323KPSLC
• Device Lot Number: 15382454
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown