MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE DRILL EXTENDER

Model Number 70-1071-SRG0014

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

The doctor did not provide any information about the patient.Expiration date: this device has no expiration date.Udi: this device was manufactured before udi was implemented for the device.This device is not an implantable device.The device investigation has been completed and the results are as follows: device history record review: the dhr was reviewed and the part met all the criteria called for in the production router.Root cause: the returned part was physically inspected in comparison with the dhr.The work order was fulfilled correctly; however, the work order calls for a peek ring to be assembled with drill extender.This peek ring, in-turn, makes the mating parts (drills) hard to remove.A design update was made to provide retention without using the peek ring.When this occurred, the packaging router was not updated to remove the peek-ring during assembly.This in turn led to the updated drill extenders being assembled with the peek ring.This in turn led to the tight fit between current drill extender and it's mating parts (drills).

Event Description

Drill extenders with drills of any size get stuck, and is hard to remove.This incident occurred on (b)(6) 2017.The product was used 2 to 4 times before during surgery.The was patient contact, but no injury occurred.

• Brand Name: INCLUSIVE DRILL EXTENDER
• Type of Device: INCLUSIVE DRILL EXTENDER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer Contact: herbert schoenhoefer ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9494402632
• MDR Report Key: 11228106
• MDR Text Key: 228625603
• Report Number: 3011649314-2017-00562
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/25/2021

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: Health Professional
• Device Model Number: 70-1071-SRG0014
• Device Catalogue Number: 70-1071-SRG0014
• Device Lot Number: 6021518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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