MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP PEEK 4.75MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP PEEK 4.75MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged and 4 sealed, ar-2324psp, serial/batch number (b)(6), were received for investigation.Visual inspection of the opened, damaged device, noted that the anchor was damaged at the distal end, the eyelet is still attached to the inserter.The o-ring and sutures were also returned.Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure is attributed to misuse due to prying/leveraging the device during use.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/17/2024, it was reported by a sales representative via email that an ar-2324psp self punching peek swivelock anchor broke during insertion.The surgeon placed the anchor on the bone and went to lightly mallet in the anchor when it immediately snapped the tip in half.Everything was removed from the patient.This was discovered during a shoulder arthroscopy procedure on (b)(6)2024.Additional information received on 10/24/2024: the case was delayed in retrieving the broken tip; additional anesthesia was not needed.

• Brand Name: SWIVELOCK, SP PEEK 4.75MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 20579117
• Report Number: 1220246-2024-08360
• Device Sequence Number: 8226878
• Product Code: MAI
• UDI-Device Identifier: 00888867384576
• UDI-Public: (01)00888867384576(11)240529(17)290430(10)15255179
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/29/2025

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: 15255179
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2024
• 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