MAUDE Adverse Event Report: PRISMATIK DENTALCRAFT, INC. INCLUSIVE ADJUSTABLE TORQUE WRENCH

Model Number 70-1071-SRG0155

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

The lot information of the reported wrench was asked; however, the office did not retain the lot information.Without the lot information, the product's udi and manufacturing date could not be traced back.The reported torque wrench was returned along with a prosthetic driver for evaluation.Visual inspection and fit check were performed on the returned wrench.There was no issue found with the initial inspection.The receiving router was reviewed and no manufacturing defect nor abnormality was found.Testing was performed and the wrench was set at 25 ncm; however, the wrench did not release during testing and continued to spin affirming the reported issue.The wrench was returned to the oem for further testing.The wrench was dissembled for a complete inspection of all internal components.The oem investigator found nothing out of ordinary with the wrench to indicate a manufacturing defect; however, minor corrosion build-up was observed on the internal components.The oem investigator concluded that minor corrosion buildup indicated an issue with device maintenance.The oem investigator advised the following cleaning procedure from the ifu, "before initial use and after each procedure, clean the torque wrench with a wet towel or disinfectant wipe.Rinse under warm tap water and wipe dry." and "the torque wrench may be autoclaved.Follow the auclave manufacturer's instructions.20 minutes at 135*c (275*f) is recommend.Do not store in sealed autoclave bag.After autoclaving, rotate the setting dial to ensure that the wrench is operating correctly." this issue is an isolated event.The issue is being tracked and trended.

Event Description

It was reported that an inclusive adjustable torque wrench failed to release while the doctor was putting the healing cap back onto the implant during a routine checkup.The wrench failed to release when it was set at 25 ncm.This wrench's malfunction caused the implant to turn and lose integration.The doctor indicated that there was no integration issue with the implant prior to the incident.There was no abnormality noted with the implant itself.There was no injury to the patient.

• Brand Name: INCLUSIVE ADJUSTABLE TORQUE WRENCH
• Type of Device: INCLUSIVE ADJUSTABLE TORQUE WRENCH
• Manufacturer (Section D): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer (Section G): PRISMATIK DENTALCRAFT, INC.; 2212 dupont drive; suite p; irvine CA 92612
• Manufacturer Contact: toan hoang ; 2212 dupont drive; suite p; irvine, CA 92612 ; 9492251235
• MDR Report Key: 8498021
• MDR Text Key: 150854111
• Report Number: 3011649314-2018-00561
• 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: company representative,health
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-1071-SRG0155
• Device Catalogue Number: 70-1071-SRG0155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 64