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

Model Number	DDK2-2.4-30X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On july 6, 2020 ad-tech received information that a drill bit snapped in half while drilling during an seeg case using a rosa robot.It was reported that the trajectory was not at an angle and irrigation with saline was used.The drill bit was replaced with a new one and the case proceeded without further incident.The broken drill bit was received on july 10, 2020 and examination showed that it was broken in two pieces, with the breaking point at a fluted area approximately 4mm into the fluted area, about 35mm from the drilling tip.There were wear marks noted thoughout the broken pieces, particularly near the breaking point of the drill bit.An initial risk assessment was conducted for this issue.According to rmf-4031-2, rev.D, line iem d10, the potential harm of mechanical energy-damage to healthy tissue was identified.Additionally, rmf-4031, rev.D, line item u13 identifies the risk of function- delay of procedure as an additional, potential risk.In this case, the patient did not experience any harm as a result of the drill bit snapping and the case was able to proceed as planned, using a new drill bit.Further investigation is ongoing.
Event or Problem Description
On july 6, 2020, ad-tech medical was notified that a drill bit snapped in half while drilling, during an seeg case using a rosa robot.

• Brand Name: CRANIAL DRILL BIT
• Common Device Name: CRANIAL DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• MDR Report Key: 10370547
• Report Number: 2183456-2020-00023
• Device Sequence Number: 2642875
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)211101(10)0135352726727728
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 726727728
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1