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 Problem Overheating of Device (1437)

Patient Problems Superficial (First Degree) Burn (2685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/18/2022

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 (b)(6) 2022, it was reported by an arthrex employee via sems that an ar-7300ds dissector blade heated up and burned when the pedal was activated.This was discovered during a procedure on (b)(6) 2022.

Manufacturer Narrative

The complaint is confirmed.The device was not returned for evaluation, but a photograph was provided.Evaluation of the photograph noted discoloration of the device's metal tip, consistent with an overheating event.The available photographic evidence along with usage information provided with the complaint are sufficient to determine a cause of misuse, due to no irrigation being utilized when activating the device.Since the device was activated outside the surgical site, no fluid management was present.Activation of arthroscopic shaver disposables without irrigation is not recommended, as described in directions for use dfu-0215-eo rev.1 section f.Precautions 9 and 10: "9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessive heat and may cause a thermal burn.".

• 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: 15914549
• MDR Text Key: 307158176
• Report Number: 1220246-2022-05872
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10888867041940
• UDI-Public: 00888867041943
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/07/2023

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 Model Number: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 14962578
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 03/07/2023
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1