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

Catalog Number	TW30
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: TORQUE WRENCH
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9500949
• Report Number: 3001617766-2019-02267
• Device Sequence Number: 19578671
• Product Code: NDP
• UDI-Device Identifier: 10841307119241
• UDI-Public: 10841307119241
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other