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	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament back up fixation surgery the peek swivelock ar-2324pslc broke inside patient when surgeon was inserting the swivelock after drilling and tapping the socket.Peek swivelock snapped distally but surgeon happy with the fixation.The part that was left in the patient was stable and holding the sutures of the back up fixation.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 23366240
• Report Number: 1220246-2025-04767
• Device Sequence Number: 13249325
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)250422(17)300331(10)15424183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15424183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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