MAUDE Adverse Event Report: ARTHREX, INC. PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH; MANUAL INSTR, GENERAL SURGICAL

Model Number PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH

Device Problem Defective Device (2588)

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

Event Date 08/16/2021

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.Complaint confirmed.Two ar-5008, batch 012046 probes were received for investigation.Visual inspection identified that the black coating on the ar-5008 probes had rubbed off in some locations along the shaft.This failure mode is investigated further under ncr.

Event Description

On 08/17/2021, it was reported by a sales representative via sems that two ar-5008 (line#1) 012045 and (line#2) 012046 black probe the finish was rubbing off onto the 4x4 sponge. this was discovered before a shoulder procedure on (b)(6) 2021.The case was completed using a different ar-5008.

• Brand Name: PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: 19192084
• MDR Text Key: 341989665
• Report Number: 1220246-2024-02460
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867102699
• UDI-Public: 00888867102699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PROBE, GRADUATED BLACK, 3.5MM TIP LENGTH
• Device Catalogue Number: AR-5008
• Device Lot Number: 012045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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