MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORPORATION CRANIAL DRILL BIT 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	02/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00024 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-2183456-2019-00024 was submitted as a conservative measure due to the recalls tied to this issue.
Event or Problem Description
On (b)(6) 2018, a distributor attended a seeg case on which the first trajectory the drill sleeve guide and drill bit fused.They had a backup and switched the tools out with a new kit which also fused.Those components were separated and lubricated with mineral oil and no additional problems occurred.There was no patient harm.

• Brand Name: CRANIAL DRILL BIT AND ACCESSORIES
• Common Device Name: DRILL SLEEVE GUIDE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORPORATION; 400 west oakview parkway; oak creek, wi
• MDR Report Key: 9713337
• Report Number: 2183456-2019-00024
• Device Sequence Number: 19445340
• Product Code: HBE
• UDI-Device Identifier: 00841823106520
• UDI-Public: (01)00841823106520(17)191001(10)0114724711101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• 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: 02/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• 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