MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL

Model Number	HT1.25
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), during the clinical procedure, the doctor could not remove the impression post and stripped 3 drivers.Per the complaint, the doctor states that he did not use a torque wrench to tighten screw but when he tried to remove the screw from the implant it was stuck.He has stripped or broken multiple tips and tried the ultra sonic to try to break up anything wedging the abutment in place, nothing worked.Additionally, the doctor has applied to up to 60 ncm of counterclockwise torque and the screw wouldn't move.The implant was extracted.
Additional Manufacturer Narrative
Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.Information for section a1, a2, a3, a4 were not available.When information becomes available, a supplemental report will be filed.

• Brand Name: HEX TOOL
• Common Device Name: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest dr.; thousand oaks CA 91362
• MDR Report Key: 8765249
• Report Number: 3001617766-2019-00298
• Device Sequence Number: 14094849
• Product Code: NDP
• UDI-Device Identifier: 10841307119609
• UDI-Public: 10841307119609
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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 Model Number: HT1.25
• Device Catalogue Number: HT1.25
• Device Lot Number: 123139
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 10/22/2020
• 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: Required Intervention