MAUDE Adverse Event Report: ARTHREX, INC. 1.9MM DRILL FOR FIBERTAK; BIT, DRILL

Model Number	1.9MM DRILL FOR FIBERTAK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-3600nd-4 drill bit broke.This was discovered during a case and broke in the patient.Per facility: "the drill was being used for a labral repair and the drill broke during use due to hard bone quality.No patient was injured during the incident and the procedure was continued with another 1.9mm drill.No fragments were left in the patient and the case was completed successfully.".
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.

• Brand Name: 1.9MM DRILL FOR FIBERTAK
• Common Device Name: BIT, DRILL
• 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: 14194000
• Report Number: 1220246-2022-04787
• Device Sequence Number: 14720958
• Product Code: HTW
• UDI-Device Identifier: 00888867102002
• UDI-Public: 00888867102002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 04/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1.9MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600ND-4
• Device Lot Number: 14790037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/25/2022
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown