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

Model Number	DSG-6.3-090-2.4N
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00025 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-2183456-2019-00025 was submitted as a conservative measure due to the recalls tied to this issue.
Event or Problem Description
An ad-tech clinical specialist observed a case in which a bit and guide (which were tested for fit prior to use by the user and were acceptable) fused.They were able to swap out the guide for their backup, use irrigation, and were able to complete the remaining trajectories without any additional fusing.There was no patient harm.

• Brand Name: CRANIAL DRILL BITS AND ACCESSORIES
• Common Device Name: DRILL SLEEVE GUIDE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• MDR Report Key: 9713577
• Report Number: 2183456-2019-00025
• Device Sequence Number: 19445341
• Product Code: HBE
• UDI-Device Identifier: 00841823106520
• UDI-Public: (01)00841823106520(17)191001(10)0114724711101
• 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
• 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: 10/01/2019
• Device Model Number: DSG-6.3-090-2.4N
• Device Catalogue Number: DSG-6.3-090-2.4N
• Device Lot Number: 711101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2018
• 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