MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd february 2026, it was reported by an arthrex employee via email that for an ar-2326pslc, peek swivelock, 3.9x17.9mm, the anchor pulled out from the patient's humeral head following attempted implantation.This was detected during a rotator cuff repair procedure on 12th february 2026.The procedure was completed as they used a larger anchor as a suitable alternative (ar-2324pslc opened and implanted.).
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: PEEK SWIVELOCK, 3.9X17.9MM
• 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: 24232756
• Report Number: 1220246-2026-00345
• Device Sequence Number: 18709471
• Product Code: MAI
• UDI-Device Identifier: 00888867289154
• UDI-Public: 00888867289154
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K101823
• 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): 05/27/2026

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, 3.9X17.9MM
• Device Catalogue Number: AR-2326PSLC
• Device Lot Number: 15478470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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