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	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the eyelet was damaged and chipped near the base.Refer to attachments.Based on the information provided which may include pictures, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.
Event or Problem Description
It was reported that during a subscapularis tendon rupture surgery the tip of the screw broke during punching into the bone.All parts were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device with the part number ar-2324bcc.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 22873178
• Report Number: 1220246-2025-03592
• Device Sequence Number: 21405196
• Product Code: MAI
• UDI-Device Identifier: 00888867384491
• UDI-Public: (01)00888867384491(11)240717(17)290630(10)15289343
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 08/22/2025

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
• Device Lot Number: 15289343
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown