MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP PEEK 5.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP PEEK 5.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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
It was reported that during a shoulder surgery the tip of the device broke.No parts remained in the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed.-visual inspection of the 5.5 mm peek swivelock® anchor, self punching with white/blue 1.3 mm suture tape, identified that the threads of the 5.5mm swivelock screw oval vents were broken off and damaged, the base edges of the eyelet, self punching swivelock, peek were damaged, and the sleeve returned was bent.-functional testing was not performed due to the damage to the device.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SWIVELOCK, SP PEEK 5.5MM
• 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: 22494460
• Report Number: 1220246-2025-02849
• Device Sequence Number: 4097073
• Product Code: MAI
• UDI-Device Identifier: 00888867384507
• UDI-Public: (01)00888867384507(11)250417(17)300331(10)15422405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222263
• 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): 09/11/2025

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 5.5MM
• Device Catalogue Number: AR-2323PSP-1
• Device Lot Number: 15422405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown