MAUDE Adverse Event Report: ARTHREX, INC. AVL 6MM CAN. CENTRAL DRILL, MODULAR; POWERED SURG ORTHOPEDIC INSTR

Model Number	AVL 6MM CAN. CENTRAL DRILL, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-9216ag serial/batch number 022133 was received for investigation.Visual evaluation found that the drill was damaged.The four straight flute was broken.The root cause of the reported failure mode is undetermined.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems, that an ar-9216ag univers vaultlock® augmented glenoid 6 mm cannulated central drill broke off.With no further details.This was discovered, during an unspecified procedure, with no patient harm.

• Brand Name: AVL 6MM CAN. CENTRAL DRILL, MODULAR
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 16809160
• Report Number: 1220246-2023-06584
• Device Sequence Number: 19582426
• Product Code: HWE
• UDI-Device Identifier: 00888867350427
• UDI-Public: 00888867350427
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: AVL 6MM CAN. CENTRAL DRILL, MODULAR
• Device Catalogue Number: AR-9216AG
• Device Lot Number: 022133
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown