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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 rotator cuff suture surgery the tip of the device broke off.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: b5, g3, h6.
Event or Problem Description
Update dw 08-sep-2025: further information was provided that the eyelet remained inside the patient but the rest of the device was removed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an ar-2324psp, with batch number 15327157, revealed that the distal end was damaged.Therefore, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.

• 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: 22664647
• Report Number: 1220246-2025-03138
• Device Sequence Number: 19762066
• Product Code: MAI
• UDI-Device Identifier: 00888867384576
• UDI-Public: (01)00888867384576(11)241004(17)290930(10)15327157
• 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,Followup
• Report Date (Section B): 10/21/2025

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: 15327157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/20/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/23/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown