MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL DRILL, 2.0 MM; BIT, DRILL

Model Number HUMERAL DRILL, 2.0 MM

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/02/2023

Event Type  malfunction  

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 Description

On (b)(6) 2023, it was reported by a sales representative via email that an ar-7720-2.0 humeral drill broke in the patient's bone during the first drilling cycle to prepare the humeral socket.The broken piece was dug out of the patient's humerus and the case was completed without further issues.This was discovered during a uclr procedure on (b)(6) 2023.

• Brand Name: HUMERAL DRILL, 2.0 MM
• Type of Device: 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: 16589535
• MDR Text Key: 311771461
• Report Number: 1220246-2023-06462
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00888867042124
• UDI-Public: 00888867042124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUMERAL DRILL, 2.0 MM
• Device Catalogue Number: AR-7720-2.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1