MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK C,4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10th june 2025, it was reported by an arthrex's employee via email that 2 units of ar-2324pslc, suture anchor, peek-swivelock® c, 4.75 x 19.1 mm, vented, its anchor broke during insertion.This was detected during a lateral collateral ligament repair surgery on (b)(6) 2025.The case was completed successfully by changing to a new ar-2324pslc.There was no patient harm, and no secondary procedure needed.
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.Complaint allegation is confirmed by the attached picture, which shows the anchor was broken off.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 of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• 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: 22411482
• Report Number: 1220246-2025-02736
• Device Sequence Number: 9673091
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)240814(17)290731(10)15302443
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15302443
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown