MAUDE Adverse Event Report: VERSAH, LLC VERSAH TAPERERD PILOT DRILL; TAPERED PILOT DRILL

Model Number VPLTT 1.3MM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

Dr (b)(6)'s dental office called stating that the tapered pilot drill 1.3mm broke in half while performing an implant surgery.The dental assistant was able to suction the broken piece from the osteotomy with the high vacuum suction so the patient would not swallow the piece.The piece that was still attached to the handpiece was discarded in the trash.There was no harm to the osteotomy or patient when the tapered pilot drill broke.Even though there was no patient harm or injury, versah has filed this report as it is industry standard to report these types of events with fda.

Event Description

During an implant surgery theversah tapered pilot drill 1.3mm broke in half.

• Brand Name: VERSAH TAPERERD PILOT DRILL
• Type of Device: TAPERED PILOT DRILL
• Manufacturer (Section D): VERSAH, LLC; 2000 spring arbor road; suite d; jackson MI 49203
• Manufacturer (Section G): VERSAH, LLC; 2000 spring arbor road; suite d; jackson MI 49203
• Manufacturer Contact: rhonda allen ; 2000 spring arbor road; suite d; jackson, MI 49203 ; 8447115585
• MDR Report Key: 8958513
• MDR Text Key: 190845947
• Report Number: 3011117802-2019-00002
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPLTT 1.3MM
• Device Catalogue Number: VPLTT 1.3MM
• Device Lot Number: 20041-02
• Is the Reporter a Health Professional?: Yes
• Device Age: 2 YR
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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