MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number 4.75MM BC KNOTLESS SWIVELOCK

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2021

Event Type  malfunction  

Event Description

On 12/29/2021, it was reported by a sales representative that an ar-2324kbcc knotless swivelock pulled out of implantation site.This was discovered during a metacarpals joint arthroplasty procedure on (b)(6) 2021.When surgeon attempted to pull the shuttling stitch that pulls the repair stitch through the anchor, it got stuck.When surgeon applied a bit more of force, the anchor pulled out.Case was completed successfully without further issues using a regular 5.5mm swivelock and inserter in the same previously prepared bone hole.

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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK
• 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: 19193878
• MDR Text Key: 341727390
• Report Number: 1220246-2024-02475
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10888867351285
• UDI-Public: 10888867351285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193503
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 13675704
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1