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

Model Number	DSG-6.3-090-2.4N
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00022 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 occured, 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.A drill bit seized in the guide and had to be replaced by a back-up.Because a replacement was readily available there was no impact to the patient.
Event or Problem Description
Customer encountered drill bit fusing to the drill sleeve guide on the 4th hole.They had a backup and successfully placed the depth electrode.The patient was not affected by the incident.

• Brand Name: CRANIAL DRILL BIT AND ACCESSORIES
• Common Device Name: DRILL SLEEVE GUIDE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 9553414
• Report Number: 2183456-2019-00022
• Device Sequence Number: 14227117
• Product Code: HBE
• UDI-Device Identifier: 00841823106520
• UDI-Public: (01)00841823106520(17)200701(10)0122657810270
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/06/2020

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: 07/01/2020
• Device Model Number: DSG-6.3-090-2.4N
• Device Catalogue Number: DSG-6.3-090-2.4N
• Device Lot Number: 810270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other