MAUDE Adverse Event Report: VERSAH, LLC PILOT DRILL; PILOT DRILL / DENTAL BUR

Model Number VPLT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Though there was no patient injury or impact on the intended surgery, a mdr is filed as the industry continues to file these events with fda.

Event Description

According to dr (b)(6)'s office, it was discovered that the pilot drill broke after drilling into the osteotomy.When the pilot drill broke, the clinician was able to retrieve the broken piece without issue.There was no patient injury and surgery was able to be performed as intended.

• Brand Name: PILOT DRILL
• Type of Device: PILOT DRILL / DENTAL BUR
• Manufacturer (Section D): VERSAH, LLC; 2500 west argyle st.; suite 300; jackson MI 49202
• Manufacturer (Section G): VERSAH, LLC; 2500 west argyle st.; suite 300; jackson MI 49202
• Manufacturer Contact: rhonda allen ; 2500 west argyle st.; suite 300; jackson, MI 49202 ; 5179903255
• MDR Report Key: 7374265
• MDR Text Key: 103930227
• Report Number: 3011117802-2018-00001
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: VPLT
• Device Lot Number: 20387-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1