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 07/11/2023

Event Type  malfunction  

Event Description

On 7/11/2023, it was reported by a sales representative via sems that an ar-8305 synergy resection shaver console had an issue.The shaver handpiece was not recognized by the console.They tried 2 different handpieces with the same result.The patient was not affected by this.They switched out the console for a different one, and the case went on fine.This occurred during use in an unspecified procedure with no patient harm.Additional information was requested.

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.

Manufacturer Narrative

(hp board) this evaluation determined that the reported event occurred due to moisture intrusion on the hand piece board caused by normal wear and tear.Refer to (b)(4) for additional failure modes and information.

• 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: 17489193
• MDR Text Key: 320690015
• Report Number: 1220246-2023-07465
• 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,Followup
• Report Date: 09/20/2023

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?: No
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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