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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the arthroscopic that the implant is cracked.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 information, 31-july-2025: further information were received that all broken parts of the implant were retrieved from the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged, ar-2324pslc-1, peek-swivelock®, batch 15421392, was received for evaluation.Visual inspection revealed that the screw was damaged at the threads.Functional testing was not performed due to the damage to the device.The most likely causes of the reported failure can be attributed to improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.Complaint confirmed.

• 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: 22793145
• Report Number: 1220246-2025-03459
• Device Sequence Number: 8264835
• Product Code: MAI
• UDI-Device Identifier: 00888867098145
• UDI-Public: (01)00888867098145(11)250210(17)300131(10)15386858
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 10/07/2025

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-1
• Device Lot Number: 15386858
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown