MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. HAHN SHORT DRIVER 03.5/4.3

Model Number 70-1071-SRG0084

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

Patient Problem Failure of Implant (1924)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned.Once the investigation is complete a supplemental report will be submitted.Glidewell direct was able to provide the following information: the driver was part of hahn surgical kit, lot 6059914, sku 70-1071-srg0090.The patients race/ethnicity was not provided when asked.

Event Description

It was reported that hahn driver got stuck into the implant connection.The provider used a driver from a hahn surgical kit.This was the first time this driver was used.The provider states that, "he set it by hand and he was unable to remove the driver from the implant and while trying to remove it, this made the osteotomy site larger." it is noted "entire implant and driver came out of osteotome.Provider used a larger diameter sized implant to fit new osteotome" which he had on hand.The standard torque value was used (35).The provider was also able to confirm that there was not an issue with the implant, he contends the fault lies with the driver.The provider notes the patient's bone type as grade iii.There is no significant medical or dental history prior to implantation.The provider notes the patient current condition as satisfactory.

Manufacturer Narrative

The dhr was reviewed and there was no evidence discovered to indicate that a product defect or non-conformity contributed to the issue.The part met all the criteria called for in the production router.Base on the investigation such as: review of dhr, and measurement of the returned part, the root cause cannot be determined.Review of the router found no deviation.The driver was measured and the results showed the driver functioned as intended.Driver was within specifications.This complaint will be kept on record for track and trending purposes.

• Brand Name: HAHN SHORT DRIVER 03.5/4.3
• Type of Device: HAHN SHORT DRIVER 03.5/4.3
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine CA 91740
• MDR Report Key: 8571096
• MDR Text Key: 146359132
• Report Number: 3011649314-2019-00138
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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
• Device Lot Number: 180108-006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 61