MAUDE Adverse Event Report: ARTHREX, INC. CHONDRALDRILL, HIP, DRILL BIT; PLATE, FIXATION, BONE

Model Number	CHONDRALDRILL¿, HIP, DRILL BIT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
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.
Event or Problem Description
It was reported during a hip arthroscopy procedure the drill bit broke in two places.All was retrieved from the patient.It was replaced with another ar-6585d and the case was completed with no further issues and the patient is fine to date.
Additional Manufacturer Narrative
It was reported that the tip of the drill had broken.Visual evaluation identified that the distal tip of the device had broken off.Due to the fractured state of the device, functional testing and accurate measurement analysis could not be conducted.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while prying / leveraging the devices.The reported event is confirmed based on the investigation of the returned product.

• Brand Name: CHONDRALDRILL, HIP, DRILL BIT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11475318
• Report Number: 1220246-2021-02714
• Device Sequence Number: 2965743
• Product Code: HRS
• UDI-Device Identifier: 00888867235922
• UDI-Public: 00888867235922
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• 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): 04/09/2021

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 Expiration Date: 10/31/2024
• Device Model Number: CHONDRALDRILL¿, HIP, DRILL BIT
• Device Catalogue Number: AR-6585D
• Device Lot Number: 10453905
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1