MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number SYNERGY RESECTION SHAVER CONSOLE

Device Problems Device Emits Odor (1425); Self-Activation or Keying (1557); Smoking (1585)

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

Event Date 02/24/2021

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 shaver works itself without pressing the button.Then an error message appeared on the console.After the restart there was a short circuit, defected mainboard and smell of burning.It was noted after the surgery.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update 01-mar-2021: the shaver was on the table when it started to work itself.An error appeared on the console but it´s unknown which error it was.After restarting the console there was a short circuit and a smell of burning from inside the console.Update 02-mar-2021: the incident happened during surgery on (b)(6) 2021.The defective device didn´t come in contact with the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

(overcurrent condition) the evaluation determined that the reported event was caused by damage to the control board.The damage was attributed to an overcurrent condition.

Manufacturer Narrative

(overcurrent condition) the evaluation determined that the reported event was due to damage to the control board.The damage was attributed to an overcurrent condition.The cause was product design related (software).

• Brand Name: SYNERGY RESECTION SHAVER CONSOLE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 11475608
• MDR Text Key: 242186795
• Report Number: 1220246-2021-02725
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: 00888867123854
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNERGY RESECTION SHAVER CONSOLE
• Device Catalogue Number: AR-8305
• Device Lot Number: 10043737
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1