MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC 30NCM TORQUE WRENCH

Catalog Number TW30

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

As per complaint (b)(4), the doctor stated that the dental tool will not engage with a dental tool fitting.

• Brand Name: 30NCM TORQUE WRENCH
• Type of Device: TORQUE WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 9500949
• MDR Text Key: 172190945
• Report Number: 3001617766-2019-02267
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119241
• UDI-Public: 10841307119241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TW30
• Device Lot Number: 143045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other