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

Model Number	SWIVELOCK, SP PEEK 4.75MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 8/16/2024, it was reported by a sales representative via email that two ar-2324psp peek swivelock sp had issues.The first peek swivelock sp was inserted properly.Once the anchor body was down to bone, the surgeon advanced the anchor.Every time the inserter was rotated it pulled on the sutures coming off the medial row of the fibertak anchor.It appeared as if the eyelet was rotating with the inserter as it was turned clockwise.When removing the peek swivelock sp, the eyelet would not come out.The eyelet was unable to be removed but everything else was.On the second lateral row of the peek swivelock sp, the surgeon used the green punch down to the second laser line to create a pilot hole.The same issue occurred with the second swivelock as it did with the first.The eyelet and the rest of the second swivelock were removed without issues.The fibertak remained in the patient.The case was completed by using two ar-2324pslc peek swivelock c for the lateral row.The patient construct was completed as normal, and there were no adverse events.This was discovered during a procedure on (b)(6) 2024.The case was not delayed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
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 of the device due to excessive force being used during insertion of the implant.

• Brand Name: SWIVELOCK, SP PEEK 4.75MM
• 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: 20169691
• Report Number: 1220246-2024-07458
• Device Sequence Number: 8249805
• Product Code: MAI
• UDI-Device Identifier: 00888867384576
• UDI-Public: 00888867384576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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): 06/27/2025

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: SWIVELOCK, SP PEEK 4.75MM
• Device Catalogue Number: AR-2324PSP
• Device Lot Number: 15088632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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