MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. CRANIAL DRILL BITS AND ACCESSORIES

Model Number	DDK2-2.4-30X
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2020-00005 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.Mdr-2183456-2020-00005 was submitted as a conservative measure due to the recalls tied to this issue.
Event or Problem Description
A user facility reported that the drill bit seized in the drill sleeve guide, possibly due to improper handling by the user facility.Back up tools were used and the case proceeded without patient harm.

• Brand Name: CRANIAL DRILL BITS AND ACCESSORIES
• Common Device Name: DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• MDR Report Key: 9711519
• Report Number: 2183456-2020-00005
• Device Sequence Number: 2449545
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)190401(10)0108085208140640
• 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: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 04/01/2019
• Device Model Number: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2183456-08212019-R-004
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other