MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE; POWERED SURG ORTHOPEDIC INSTR

Model Number SYNERGY RESECTION SHAVER CONSOLE

Device Problem Defective Device (2588)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information: h6 (use error) the reported event of "an ar-8305 console is showing an error message once the footswitch is connected" was confirmed.This evaluation determined that the reported event occurred due to moisture intrusion resulting from use error.

Event Description

On 08/16/2023, it was reported by a sales representative via sems that an ar-8305 console is showing an error message once the footswitch is connected.This was discovered during a procedure with no patient harm.

• Brand Name: SYNERGY RESECTION SHAVER CONSOLE
• Type of Device: POWERED SURG ORTHOPEDIC INSTR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17737054
• MDR Text Key: 323284999
• Report Number: 1220246-2023-07870
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867123854
• UDI-Public: 00888867123854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/13/2023

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
• Device Lot Number: 10210943
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1