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

Model Number	HT2.5
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age, sex, date of event and pma/510k are unknown.
Event or Problem Description
Per complaint (b)(4), components could not be separated.There was no patient impact noted.

• Brand Name: HEX TOOL
• Common Device Name: DENTAL HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest dr.; thousand oaks, ca
• MDR Report Key: 9793628
• Report Number: 3001617766-2020-00592
• Device Sequence Number: 2225293
• Product Code: NDP
• UDI-Device Identifier: 10841307119630
• UDI-Public: 10841307119630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Expiration Date: 06/18/2018
• Device Model Number: HT2.5
• Device Catalogue Number: HT2.5
• Device Lot Number: 43952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/05/2020
• 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