MAUDE Adverse Event Report: ARTHREX, INC. DRILLSAW HIGHSPEED 200; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILLSAW HIGHSPEED 200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
It was reported that during a surgery when attaching to the device two different errors appeared.One that stated that the unit is not recognised and another that there is an error of the unit.There was no harm or adverse event for patient, operator or third party reported.No further information received.Update avoe 19-jun-2023: it was further reported that the failure was noticed before the surgery when connecting the devices shortly before the surgery.A minimally invasive surgery was planned with the reported device.Due to the failure the surgeon had to switch the hallux rigidus procedure by opening the joint to an open surgery.The surgery was finished successfully with different devices (stryker saw and drill).It was not necessary to do a second surgery.Update avoe 19-jun-2023: it was confirmed that the patient was already anesthetized when the error was noticed.
Additional Manufacturer Narrative
Event description: it was reported that during a surgery when attaching to the device two different errors appeared.One that stated that the unit is not recognised and another that there is an error of the unit.The reported event was confirmed.The manufacturers evaluation revealed a defective stator of the motor.The device does not recognize the motor which resulted in the reported event.Most likely causes for the observed condition are physical damage to the device, contamination of the motor and/or high temperature form continuous use.

• Brand Name: DRILLSAW HIGHSPEED 200
• Common Device Name: 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: 17286640
• Report Number: 1220246-2023-07089
• Device Sequence Number: 16896808
• Product Code: HWE
• UDI-Device Identifier: 00888867184169
• UDI-Public: 00888867184169
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRILLSAW HIGHSPEED 200
• Device Catalogue Number: AR-200
• Device Lot Number: 14944355
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown