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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

On 7/28/2022, it was reported by a sales representative via email that an ar-8980bc dx knotless swivelock anchor slid into the shaft and pulled out when shaft was removed from the patient.Surgeon tapped again and used an ar-2324pslc peek-swivelock, which the anchor also slid into the driver shaft and pulled out when it was removed.Finally, an ar-1540ps peek tenodesis screw was used to complete the case.This was discovered during a patella tendon repair procedure on (b)(6) 2022.

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.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: PEEK SWIVELOCK C,4.75X19.1MM
• Type of Device: 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: 19174342
• MDR Text Key: 340969543
• Report Number: 1220246-2024-02321
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: 00888867026919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 14101887
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1