MAUDE Adverse Event Report: ARTHREX, INC. DRILLSAW HIGHSPEED 200; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILLSAW HIGHSPEED 200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-200 instrument is not recognized when plugged in, which displayed a console error saying "handpiece not attached (?)".This was discovered out-of-box during an arthroscopic procedure on (b)(6) 2022.The case was completed by an open technique as minimally invasive surgery was not possible.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-200m motor with cable 3.5 m serial/batch number (b)(6) was received for investigation.Functional testing with ar-200c, serial (b)(6)found that the device does not function as required.When the device is connected to the console a screen error appears, not handpiece attached symbol (?).Visual evaluation of the cable or connector did not found issues.The root cause of the reported failure mode is undetermined.

• Brand Name: DRILLSAW HIGHSPEED 200
• Common Device Name: 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: 15758613
• Report Number: 1220246-2022-05723
• Device Sequence Number: 6352601
• Product Code: HWE
• UDI-Device Identifier: 00888867184169
• UDI-Public: 00888867184169
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: DRILLSAW HIGHSPEED 200
• Device Catalogue Number: AR-200
• Device Lot Number: 14954327
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown