MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN TAPERED IMPLANT DRIVER 3.5/4.3 SHORT

Model Number 70-1071-SRG0084

Device Problem Break (1069)

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

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not been returned.However, there will be a non-visual investigation carried out.The patients' age was provided.However the age at the time of event is unknown.Date of birth was asked but not provided.Lot information was not provided by the customer.Expiration date and udi are not available.Lot number is not available therefore the device manufacturer date is not available.

Event Description

It was reported that an implant driver failed.The patient presented on (b)(6) 2020 for primary procedure on tooth #3.During placement the provider notes "the implant driver fractured and the tip sheared off and left a portion in the implant".The provider states the patients current status as "satisfactory".

Manufacturer Narrative

B4: date of this report is 08-06-20.This information was omitted from the initial submission.The device investigation has been completed and the results are as follows: dhr results: unable to review the router since the lot number was not provided.Stock product reviewed results: unable to review the stock product since the lot number was not provided.Investigation methods/results: customer did not return the driver but returned an implant for investigation.The returned implant was verified to be hahn 4.3 x 10 mm implant using radiographic template.Meeting with sme and qe on 12/14/20 and confirmed debris can be observed inside the implant.However, it was unknown if debris contains any driver tip.Customer did not return any broken driver for inspection.Root cause: the root cause cannot be explicitly determined.The possible cause was physician did not fully engaged the driver with implant during the placement, causing excessive force was applied.However, customer did not return the driver for inspection.Supplemental follow up was submitted late due to additional time needed for completion.

• Brand Name: HAHN TAPERED IMPLANT DRIVER 3.5/4.3 SHORT
• Type of Device: HAHN TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• MDR Report Key: 10377131
• MDR Text Key: 202004050
• Report Number: 3011649314-2020-00599
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0084
• Device Catalogue Number: 70-1071-SRG0084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 64