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

Model Number DISSECTOR, 3.0MM X 7CM

Device Problems Break (1069); Dull, Blunt (2407)

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

Event Date 09/03/2021

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported on (b)(6) 2021 by a facility representative via sems that an ar-9300ds dissectors teeth are dulling and metal shavings are breaking off inside the patient.This was discovered during a case with no patient impact.

Manufacturer Narrative

Complaint confirmed.Visual inspection under magnification identified the presence of circumferential grooves worn into the inner diameter of the outer tube hood, as well as chipping along the outer diameter of the cutting window, consistent with sites of metal debris production.The cutting blades were noted to be intact, although tissue remnants were found caught within the blades.The cause remains undetermined, although a probable cause of the debris production can be attributed to prying/leveraging the device against bone and/or hard tissue during use.

• Brand Name: DISSECTOR, 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
• MDR Report Key: 12507564
• MDR Text Key: 273583070
• Report Number: 1220246-2021-03688
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867211834
• UDI-Public: 00888867211834
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DISSECTOR, 3.0MM X 7CM
• Device Catalogue Number: AR-9300DS
• Device Lot Number: 13022649
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2021
• Patient Sequence Number: 1