MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number DISSECTOR, SJ 3.0MM X 7CM

Device Problems Thermal Decomposition of Device (1071); Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2022

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 03/29/2022, it was reported by a distributor via email that an ar-7300ds dissector generated a small combustion.This was discovered during a procedure on (b)(6) 2022.

Manufacturer Narrative

The complaint is not confirmed.While the device was not returned and no pictures were provided, per the event description is concluded that the most likely cause for the event reported is misuse.The information available indicates the device was activated outside the surgical site without irrigation for testing purposes.Activating the device outside the surgical site without irrigation (dry environment) characterizes misuse and may cause overheating.

• Brand Name: DISSECTOR, SJ 3.0MM X 7CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, 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: vik bajnath ; 8009337001
• MDR Report Key: 14135475
• MDR Text Key: 298907209
• Report Number: 1220246-2022-04739
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 13735464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1