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 Smoking (1585); Material Twisted/Bent (2981)

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

Event Date 02/12/2021

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.

Event Description

It was reported that the ar-7300ds was connected to the shaver and outside of the patient when it started to smolder at the base of the shaver shaft.It lit up red hot and bent.The rep reported the issue occurred at the very end of the ankle scope when the shaver was outside of the patient.No one was hurt or affected by the device.

Manufacturer Narrative

The complaint is confirmed.The reported device was not returned for investigation.Pictures were provided for evaluation.Upon picture evaluation and per the event description is inferred that the cause for the reported failure is most likely attributed to misuse; abnormal use: the information available indicates the device was activated outside the surgical site without irrigation.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: 11392657
• MDR Text Key: 238833535
• Report Number: 1220246-2021-02631
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: 00888867041943
• 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: 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: 03/01/2021
• Is this an Adverse Event Report?: Yes
• 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: 10716089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• 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