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 Display or Visual Feedback Problem (1184); Device Emits Odor (1425); Smoking (1585)

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

Event Date 04/12/2021

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

Event Description

It was reported that a "critical error" message pops up and burning smell occurs.No case involvement.

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) complaint confirmed.The evaluation determined that the reported event was caused by damage to the control board.The damage was attributed to an overcurrent condition.The cause is due to product design (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: 11761728
• MDR Text Key: 250949017
• Report Number: 1220246-2021-03013
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: 00888867123854
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K932699
• 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,Followup
• Report Date: 06/06/2023

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: SYNERGY RESECTION SHAVER CONSOLE
• Device Catalogue Number: AR-8305
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 04/12/2021
• Supplement Dates FDA Received: 09/08/2021; 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1