MAUDE Adverse Event Report: ARTHREX, INC. 6MM QUICK RELEASE GLENOID DRILL, SHORT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6MM QUICK RELEASE GLENOID DRILL, SHORT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the device was received with a broken tip.The device broke about 1 cm from the distal end.Circumferential abrasion marks were observed on the od of the device.The device od and material also met specifications.The cause is undetermined, however likely causes include prying/leveraging the device or hitting another object.
Event or Problem Description
It was reported the during a procedure, when the surgeon was drilling the proximal hole in the small vaultlock glenoid guide with the short 6.0 drill bit, while drilling with the drill bit it snapped in half.The case was completed by using another ar-9221 without further issue.

• Brand Name: 6MM QUICK RELEASE GLENOID DRILL, SHORT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11705645
• Report Number: 1220246-2021-02935
• Device Sequence Number: 3846773
• Product Code: LXH
• UDI-Device Identifier: 00888867059177
• UDI-Public: 00888867059177
• 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): 04/22/2021

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: 6MM QUICK RELEASE GLENOID DRILL, SHORT
• Device Catalogue Number: AR-9221
• Device Lot Number: 021605
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1