MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-300,HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	ARTHREX AR-300,HANDPIECE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/ is expected but has not been returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a hallux valgus osteotomy the handpiece did not work.Pushing the trigger did not lead to motor movement.It was further reported that liquid was going out of the trigger point.There was no harm for patient, operator or third party reported.No further information received.Update 14-apr-2020: further information was provided that the reported event was identified at the start of the surgery.The patient was already in place and under proper anesthesia.Before the first cut was made it was found that the trigger of the device did not work and as the customer has no backup device the surgery was stopped and postponed.
Additional Manufacturer Narrative
Vendor evaluation confirmed the device did not function and a crack was found in the material.The electronic board was found to be damaged.A likely cause is heat damage during the sterilization process.

• Brand Name: ARTHREX AR-300,HANDPIECE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10028206
• Report Number: 1220246-2020-01821
• Device Sequence Number: 3122666
• Product Code: HWE
• UDI-Device Identifier: 00888867099357
• UDI-Public: 00888867099357
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ARTHREX AR-300,HANDPIECE
• Device Catalogue Number: AR-300
• Device Lot Number: 10158550
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 08/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other