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

Model Number VPLT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

Upon receipt of the returned unit, the manufacturer completed an investigation and determined that the product was made to specification, including proper core diameter and outside diameter.

Event Description

According to dr.(b)(6) office, it was discovered that the pilot drill broke when preparing for osteotomy in the mandible.The clinician was able to retrieve the broken part of the drill without issue.There was no patient injury and surgery was performed, as intended.

• Brand Name: PILOT DRILL
• Type of Device: PILOT DRILL / 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: 6789036
• MDR Text Key: 82763558
• Report Number: 3011117802-2017-00001
• 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: 08/11/2017

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: Dentist
• Device Model Number: VPLT
• Device Catalogue Number: VPLT
• Device Lot Number: 20041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1