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 Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.Upon visual inspection, it was noted that the screw was twisted/deformed.Upon functional testing, it was noted that the screw could not be removed from the device.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.
Event or Problem Description
It was reported that during a shoulder arthroscopy the implant could not be anchored.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.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.

• 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: 19278189
• Report Number: 1220246-2024-03029
• Device Sequence Number: 7649454
• Product Code: MAI
• UDI-Device Identifier: 00888867098145
• UDI-Public: 00888867098145
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K203495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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
• Device Expiration Date: 06/30/2026
• Device Model Number: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC-1
• Device Lot Number: 13722429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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