MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. CRAINIAL DRILL BIT; CRANIAL DRILL BIT

Model Number	DDK2-2.4-30X
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, ad-tech medical was notified that a drill bit broke during placement of the last electrode.

• Brand Name: CRAINIAL DRILL BIT
• Common Device Name: CRANIAL DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 11056308
• Report Number: 2183456-2020-00028
• Device Sequence Number: 3311221
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)210501(10)0131711208140713
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: No Information
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140713
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1