MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-600,HANDPIECE; POWERED SURG ORTHOPEDIC INSTR

Model Number ARTHREX AR-600,HANDPIECE

Device Problems Defective Device (2588); Intermittent Loss of Power (4016)

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

Event Date 08/25/2023

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 the device stops sporadically.The problem was noticed before the surgery.There was no harm for the patient, operator or third party reported.Update avoe 29-aug-2023.It was confirmed that the error occurred during a endoprosthetic joint replacement surgery.The error led to an increased surgery time.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The reported event was confirmed.The manufacturer evaluation revealed deposits on stator contacts and stator winding (see evaluation pictures).Furthermore, minor damages at sensor electronics had been found.A most likely cause might be attributed to improper device maintenance.

• Brand Name: ARTHREX AR-600,HANDPIECE
• 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: 17775573
• MDR Text Key: 323848667
• Report Number: 1220246-2023-07955
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 01/12/2024

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: ARTHREX AR-600,HANDPIECE
• Device Catalogue Number: AR-600
• Device Lot Number: 11802548
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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