MAUDE Adverse Event Report: ARTHREX, INC. 2.9MM BIOCOMPOSITE PUSHLOCK KIT; BIO SOFT TISSUE FIXATN FASTNR

Model Number 2.9MM BIOCOMPOSITE PUSHLOCK KIT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 1/30/2024, it was reported by an arthrex subsidiary employee via email that an ar-2923bc-k implant system biocomposite pushlock anchor pulled out after insertion.A 2.9 pushlock drill bit was used to prepare the bone socket.All broken parts were retrieved from the patient, and the case was completed using another ar-2923bc-k from an unknown lot.There was no case delay and no additional anesthesia administered.This was discovered during a bankart procedure on (b)(6) 2023, with no patient harm reported.

• Brand Name: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• 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: 18730802
• MDR Text Key: 335731889
• Report Number: 1220246-2024-01025
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K101679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/19/2024

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 Operator: Health Professional
• Device Model Number: 2.9MM BIOCOMPOSITE PUSHLOCK KIT
• Device Catalogue Number: AR-2923BC-K
• Device Lot Number: 15133979
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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