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

Catalog Number DDK2-2.4-30X

Device Problem Break (1069)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

While using a 2.45mm rosa guide during a case, the drill bit broke.There was no impact to the patient, and the case proceeded as planned after swapping out components.

Event Description

While using a 2.45mm rosa guide during a case, the drill bit broke.There was no impact to the patient, and the case proceeded as planned after swapping out components.

• Brand Name: CRANIAL 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: erika keller ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 11920851
• MDR Text Key: 256798238
• Report Number: 2183456-2021-00005
• 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: Other
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DDK2-2.4-30X
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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