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

Model Number 70-1071-SRG0085

Device Problem Break (1069)

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

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth: this information was not provided when asked.Weight: this information was not provided when asked.The patients race/ethnicity was not provided when asked.The device investigation has been completed and the results are as follows: dhr results: 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.Stock product results: stock ø3.5/4.3 drivers were dimensionally inspected with the drawing and fit checked with the hand piece connection.They fit as intended.Returned sample results: the returned device was hahn tapered implant driver ø3.5/4.3 long.The section of the iso latch tip was broken off as indicated in the complaint.It broke off at the slimmest section of the latch which is the groove.Investigation results: the returned part was physically inspected and in comparison with the dhr.As returned, the part is defective as it has a section broken off.The stock parts were visually and dimensionally checked to ensure the part is made to specification.The stock parts were fit checked to a handpiece and confirmed to engage and latch on as intended.Root cause: the root cause for the breaking is due to excessive forces being applied to the latch section of the driver.However, it is unclear what caused the excessive force to be applied at that location while using the wrench with the adaptor.The adaptor is designed such that the force is applied to the hexagonal section of the driver as opposed to the iso latch during torquing.It might be the case that the wrench to adaptor to implant driver assembly was not properly set up prior to the application of torque which has led to this issue of breakage.

Event Description

It was reported that the "hahn driver failed.It broke at the top latch, and while it was used on the patient.The implant incident occurred on (b)(6) 2016.The hand piece was nsk surgical model xt that was used with the driver.It did latch in all the way.The setting was set around 50 (slow).The dentist used the hand piece half way, then the hahn wrench (from the kit) was used.The driver broke when the wrench was used.The torque force was at the recommended level.

• Brand Name: HAHN TAPERED IMPLANT DRIVER 3.5/4.3 LONG
• Type of Device: HAHN TAPERED IMPLANT DRIVER
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine, ca
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont dr; suite p; irvine, ca
• Manufacturer Contact: herbert schoenhoefer ; 2212 dupont drive; suite p; irvine, ; 3130850
• MDR Report Key: 10428830
• MDR Text Key: 203658882
• Report Number: 3011649314-2017-00540
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0085
• Device Catalogue Number: 70-1071-SRG0085
• Device Lot Number: 6030650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1