MAUDE Adverse Event Report: ARTHREX, INC. 4.5MM QUICK RELEASE DRILL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	4.5MM QUICK RELEASE DRILL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2021
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 that the tip of the ar-9239 broke when drilling the glenoid, for a total shoulder case.The tip was retrieved from the patient.
Additional Manufacturer Narrative
Complaint confirmed, the tip of the device broke off.Circumferential abrasion marks were observed near the breakage.The cause of the event is undetermined, however a likely cause is prying/leveraging the device during use.

• Brand Name: 4.5MM QUICK RELEASE DRILL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11437186
• Report Number: 1220246-2021-02695
• Device Sequence Number: 5170118
• Product Code: MDM
• UDI-Device Identifier: 00888867059528
• UDI-Public: 00888867059528
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 Model Number: 4.5MM QUICK RELEASE DRILL
• Device Catalogue Number: AR-9239
• Device Lot Number: 021740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1