MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL FOR FIBERTAK; BIT, DRILL

Model Number	1.8MM DRILL FOR FIBERTAK
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
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
It was reported on (b)(6) 2022 by a arthrex employee via sems that an ar-3600d-2 drill for fibertak broke during use.Case involvement, device broke during use.Additional information requested (b)(6) 2022.Response:(b)(6) 20/22 stated that drill bit broke inside the patient, all fragments retrieved.
Event or Problem Description
It was reported on 11/23/2022 by a arthrex employee via sems that an ar-3600d-2 drill for fibertak broke during use.Case involvement, device broke during use.Additional information requested 11/28/22 response 12/1/22 stated that drill bit broke inside the patient, all fragments retrieved.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual investigation, it was determined that both flutes were cut from the drill, and only one of the returned flutes is broken at the distal tip.The most likely reason for this issue is caused by applying excessive leverage force.However, the broken piece was not returned for investigation.The cause remains undetermined.

• Brand Name: 1.8MM 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: 15959143
• Report Number: 1220246-2022-05925
• Device Sequence Number: 4938579
• Product Code: HTW
• UDI-Device Identifier: 00888867101913
• UDI-Public: 00888867101913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 1.8MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown