MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC THOUSAND O SPECTRA-SYSTEM®/ LEGACY¿ GUIDED SURGERY HANDLE KIT; GUIDED HANDLE KIT

Model Number	G-HK
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The 2.3 guide insert will not allow the 2.3 drill to pass through, the diameter is too small.

• Brand Name: SPECTRA-SYSTEM®/ LEGACY¿ GUIDED SURGERY HANDLE KIT
• Common Device Name: GUIDED HANDLE KIT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC THOUSAND O; 3050 e. hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 6632595
• Report Number: 3001617766-2017-00002
• Device Sequence Number: 11610
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: G-HK
• Device Catalogue Number: G-HK
• Device Lot Number: 65249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1