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

Catalog Number DDK2-2.4-30X

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

During an seeg depth case using an ad-tech drill guide, the drill bit fused with the guide while drilling causing the bit to break.The guide and bit were able to be separated and the case proceeded with another bit as planned with no impact to the patient.

Manufacturer Narrative

Although this complaint is primarily regarding the broken drill bit, recall 2183456-08212019-r-004 is referenced as communication with the user indicates that an ad-tech dsg, which was knowingly not returned in the recall, was used in the case.A return of the broken drill bit is expected and a followup report will be filed when more information is available.

• Brand Name: CRAINIAL DRILL BIT
• Type of Device: CRAINIAL 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 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 14245562
• MDR Text Key: 290538851
• Report Number: 2183456-2022-00009
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 0841823101167
• UDI-Public: (01)0841823101167(17)230201(10)0144050756757758
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 756757758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2183456-08212019-R-004
• Patient Sequence Number: 1