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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure is user error.Per dfu-0087-11.G.Precautions.5.Pushlock and swivelock suture anchor only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during the final advancement of the anchor body.

Event Description

It was reported that a biocomposite knotless swivelock, ar-2324kbcc, was being used in a procedure.When putting the anchor into the punched bone tunnel, the two fibertapes that were in the eyelet, ripped through the edge of the peek eyelet.The surgeon replaced with an ar-2324bcc, with lot# 11772467.No fragments were left in the patient from the broken eyelet piece and the surgery was completed successfully with no adverse effect to the patient.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18300034
• MDR Text Key: 330117969
• Report Number: 1220246-2023-09332
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/11/2023

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 Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 10984717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1