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

Catalog Number	DDK2-2.4-30X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the event description section, ad-tech responded back to the customer the day they were notified to obtain additional information.To date, the customer has not responded back.Thus, it is unknown what the outcome/current status is of the patient or if it is possible that the drill bit broke during an oblique trajectory.A follow-up email was sent to the customer on 8/2/2017.This medwatch report was inadvertently submitted to the fda past the 30 timeframe in hopes to obtain the additional information for this report.An internal complaint investigation was performed for this issue.Specifically, a historical complaints review was completed for the alleged deficiency "drill bit broke while drilling".There have been zero (0) similar complaints for broken drill bits between 1/1/2015 and 6/5/2017.Based on this review, no trend exists in regards to broken drill bits out in the field.A batch record review was also performed on 6/13/2017 for the impacted product (lot 208140633, batch# 105816).(b)(4) drill kits were planned for this work order and (b)(4) were completed.There were no additional issues noted in the work order process notes that would contribute to the reported complaint and all kits passed the in-process and final qc checks.This investigation is still on-going.
Event or Problem Description
On june 5, 2017, ad-tech medical received an email from a customer stating that "during drilling this bit broke and was lodged deep to the skull".Ad-tech responded back to the customer that day to obtain additional information to help aid with the complaint investigation.To date, the customer has not responded back.It is unknown what the outcome or current status is of the patient.A supplement report will be initiated should ad-tech receive additional information relevant to this medwatch report.

• Brand Name: DRILL BIT
• Common Device Name: DRILL BIT
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 1901 william street; racine WI 53404
• MDR Report Key: 6761983
• Report Number: 2183456-2017-00006
• Device Sequence Number: 1853180
• Product Code: HTW
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)190101(10)0105816208140633
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: No Information
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140633
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 08/02/2017
• 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