MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER Ø3.0 LONG

Model Number 70-1071-SRG0083

Device Problem Accessory Incompatible (1004)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was asked; however, the doctor advised it was some time in (b)(6) 2018.Patient's date of birth and age were asked; however, the information has not been provided.Follow-ups were made to request more information; however, some information are still pending from the doctor.The reported device was received and the evaluation is anticipated.Once the investigation is completed, a supplemental report will be submitted.This report for is the 1st of 3 reported implant drivers: please reference 3011649314-2018-00454 ((b)(6)) for the 2nd implant driver.Please reference 3011649314-2018-00455 ((b)(6)) for the 3rd implant driver.

Event Description

This report is for the 1st of 3 failed implant drivers: it was reported that a long hahn tapered implant driver ø3.0 failed to engage properly.Per provided information, the implant driver would spin freely even though the doctor reported proper size implant driver was used.The doctor could not reach the desired depth or could not back the implant out to re-drill.There was no known injury to the patient.

Manufacturer Narrative

The reported driver was returned for evaluation.A visual and microscropic inspection were performed on the returned driver.The critical parameters of the driver were measured and no defects, nor non-conformities were found.A lot number was received and a device history record review (dhr) was conducted.There was no evidence to indicate that a product defect or nonconformity contributed to the issue.The driver met all the criteria called for in the production router.A fit test was performed on the driver using a stocked implant.The driver could be fully seated inside the implant.There was no engagement issue observed between the driver and stocked implant.A second fit test was also performed on the driver using both a stocked handpiece and a stocked surgical wrench.The driver latched onto the handpiece and surgical wrench without any issue.There was no engagement issue found with the driver to the handpiece nor the surgical wrench.The driver did not "spin freely" during testing.Based on the investigation, the root cause could not be determined as the driver functioned as intended.Without the associated implant returned, the exact replication of the event could not be performed.The reported issue could not be confirmed.This event will be tracked and trended.

• Brand Name: HAHN TAPERED IMPLANT DRIVER Ø3.0 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER Ø3.0 LONG
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• MDR Report Key: 8215656
• MDR Text Key: 132569414
• Report Number: 3011649314-2018-00453
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0083
• Device Catalogue Number: 70-1071-SRG0083
• Device Lot Number: 6026303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 73