MAUDE Adverse Event Report: ARTHREX, INC. DRILL JACOBS CHUCK 0-4.0 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number DRILL JACOBS CHUCK 0-4.0 MM

Device Problem Defective Device (2588)

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

Event Date 05/12/2021

Event Type  malfunction  

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.Event description: it was reported that the device emits a strange sound and vibrates uncharacteristically.The reported event was confirmed as the manufacturer evaluation revealed the planetary gear is not running smoothly.

Event Description

It was reported that the device emits a strange sound and vibrates uncharacteristically.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: DRILL JACOBS CHUCK 0-4.0 MM
• Type of Device: POWERED SURG ORTHOPEDIC INSTR
• 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: 19190777
• MDR Text Key: 341576799
• Report Number: 1220246-2024-02440
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867100091
• UDI-Public: 00888867100091
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: DRILL JACOBS CHUCK 0-4.0 MM
• Device Catalogue Number: AR-300DJ
• Device Lot Number: 10221323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1