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

Model Number	DDK2-2.4-30X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00014 has been filed past the 30-day timeframe.Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occurred, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur.As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Event or Problem Description
On (b)(6) 2018, an ad-tech clinical specialist attended a case where the doctor experienced an issue with a broken drill bit.According to the clinical specialist, it was stated that the doctor was drilling into the patient's skull and halfway through, the drill bit snapped off.There was no known impact to patient safety.

• Brand Name: AD-TECH 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: 9729114
• Report Number: 2183456-2019-00014
• Device Sequence Number: 19343098
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)200301(10)0118632208140667R
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140667R (0118632)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1