MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX WRENCH IMPLANT DRIVER; DENTAL IMPLANT DRIVER

Catalog Number	HT3.0LG
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer will be contacted.
Event or Problem Description
As per complaint (b)(4) during a clinical procedure a dental implants components could not be separated and the implant was removed.There was 1 patient involved in this event.
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 h6 to report that the device was not received for analysis.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: HEX WRENCH IMPLANT DRIVER
• Common Device Name: DENTAL IMPLANT DRIVER
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks, ca
• MDR Report Key: 10363968
• Report Number: 3001617766-2020-06027
• Device Sequence Number: 11628853
• Product Code: NDP
• UDI-Device Identifier: 10841307119890
• UDI-Public: 10841307119890
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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: Physician Assistant
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: HT3.0LG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 05/27/2021
• 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
• Patient Age: 63 YR