MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK C,4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK C,4.75X19.1MM
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
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 foot surgery the suture was frayed.The defect was noticed after implantation.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the device.The defective suture was not used.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• 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: 25316161
• Report Number: 1220246-2026-03031
• Device Sequence Number: 14766039
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)251231(17)301130(10)15551581
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203495
• 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): 05/28/2026

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 C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15551581
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown