MAUDE Adverse Event Report: ARTHREX, INC. OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH

Device Problems Break (1069); Component Missing (2306); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2019

Event Type  Injury  

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 a shoulder arthroscopy was performed with an arthrex device.The head of the probe got deformed and detached by the effect of heat.According to the surgeon the detached fragment was not retrieved.No further information received at the moment.Update 25-oct-2019: after the surgery it was found that the probe had a broken edge on the head and a small piece was missing, the joint was well washed and searched for the missing piece, but was not found.

Manufacturer Narrative

Complaint confirmed.Visual evaluation revealed a portion of the ceramic head broken-off at the top left of the ceramic head facing the electrodes.Also, heat damaged was noticed at the top of the head, as a result of the broken piece of the ceramic.A most likely cause for this event to occur is by mechanical damage to device such as hitting the device with another device, prying/leveraging the device ,and/or running the device longer than intended during use.

• Brand Name: OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9324242
• MDR Text Key: 166520878
• Report Number: 1220246-2019-01410
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867062627
• UDI-Public: 00888867062627
• Combination Product (y/n): N
• PMA/PMN Number: K023986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
• Device Catalogue Number: AR-9705A-90
• Device Lot Number: 1711183
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 12/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other