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

Catalog Number DDK2-2.4-30X

Device Problem Break (1069)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

A drill bit broke during a trajectory that was located in the frontal region, which was quite skivey, and thought to be a difficult trajectory.

• Brand Name: DRILL BIT
• Type of Device: CRANIAL 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: 14945345
• MDR Text Key: 295421241
• Report Number: 2183456-2022-00015
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 07/07/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 786787788
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1