MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-600,HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number ARTHREX AR-600,HANDPIECE

Device Problem Overheating of Device (1437)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported that during a knee surgery the device suddenly overheated and totally stopped working when the device was used during the insertion of an uniknee prothesis.The handle was too hot to keep it in hands.The surgeon had to change to an old hall drill to finish the surgery, the drill haven¿t been tried after it was cooled down.According to the surgeon no harm for patient, operator or third party occurred.No further information received.

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

The manufacturers evaluation revealed that the complaint device heated up after 15-20 seconds of testing.The device was disassembled and the sensor magnet was found rotated by approximately 90° in relation to the control magnet.If these magnets are not aligned properly it will result in an increased heat.Further, a louder running noise of the planetary gear can be recognized which also indicates a damage of the bearing.A definite cause for the misalignment of the sensor magnet could not be determined and therefore remains unknown.The reported event was confirmed.

• Brand Name: ARTHREX AR-600,HANDPIECE
• 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: 12953362
• MDR Text Key: 281910338
• Report Number: 1220246-2021-04051
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867110175
• UDI-Public: 00888867110175
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ARTHREX AR-600,HANDPIECE
• Device Catalogue Number: AR-600
• Device Lot Number: 10305485
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other