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

Model Number	DDK2-2.4-30X
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00011 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-2183456-2019-00011 was submitted as a conservative measure due to the recalls tied to this issue.
Event or Problem Description
On (b)(6) 2017 an ad-tech clinical specialist attending a surgical case observed that the drill bit fused with the drill sleeve guide and broke.The surgery was able to be finished using alternative equipment and there was no reported injury to the patient.
Event or Problem Description
On 11/8/2017 an ad-tech clinical specialist attending a surgical case observed that the drill bit fused with the drill sleeve guide and broke.The surgery was able to be finished using alternative equipment and there was no reported injury to the patient.
Additional Manufacturer Narrative
Updated 7/22/2022: root cause of the fusion of the drill sleeve guide to the drill bit was not able to be determined as part of this complaint return analysis.Per the risk assessment, the calculated occurence matches the applicable risk file and the risk level remains "as low as possible" and no risk updates are needed at this time.

• 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 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 oakview parkway; oak creek WI 53154
• Manufacturer Contact: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 9712651
• Report Number: 2183456-2019-00011
• Device Sequence Number: 2449547
• Product Code: HBE
• UDI-Device Identifier: 00841823101167
• UDI-Public: (01)00841823101167(17)191001(10)0114788208140656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: DDK2-2.4-30X
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown