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

Catalog Number DDK2-2.4-30X

Device Problem Break (1069)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

While using a 2.45mm rosa guide during a case, the drill bit broke prior to coming in contact with the patient.There was no impact to the patient, and there was a slight delay but the case did proceed as planned.

Event Description

While using a 2.45mm rosa guide during a case, the drill bit broke prior to coming in contact with the patient.There was no impact to the patient, and the case proceeded as planned.

Event Description

While using a 2.45mm rosa guide during a case, the drill bit broke prior to coming in contact with the patient.There was no impact to the patient, and the case proceeded as planned.

Manufacturer Narrative

While using a 2.45mm rosa guide during a case, the drill bit broke prior to coming in contact with the patient.There was no impact to the patient, and there was a slight delay but the case did proceed as planned.Updated 5/25/2022.As documented within the complaint, there was no impact to the patient as a result of this issue.Per our risk assessment, the risk remains alap (as low as possible) and matches that of the risk file.No updates to the risk file are needed at this time.The rosa drill guide and ad-tech drill bit were not returned to ad-tech, therefore, no further evaluation could be performed.Based on the information above, the cause was deemed inconclusive and no further corrective actions were assigned.This complaint was closed and the trend code is being monitored for future occurrence.

• 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: nicole remer ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 11837779
• MDR Text Key: 263220448
• Report Number: 2183456-2021-00004
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 08418231011671
• UDI-Public: 01084182310116717210601100132400208140714
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: DDK2-2.4-30X
• Device Lot Number: 208140714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1