MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISSPLANT 3.2MMD STRAIGHT DRILL; POWERED BONE DRILL

Model Number	SPD3.2
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) japan distributor found during incoming inspection, a lack of matted laser marking in order to show 18 mm depth on a drill in the swish system basic surgical tray.

• Brand Name: SWISSPLANT 3.2MMD STRAIGHT DRILL
• Common Device Name: POWERED BONE DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7406570
• Report Number: 3001617766-2018-00057
• Device Sequence Number: 786010
• Product Code: DZI
• UDI-Device Identifier: 10841307117391
• UDI-Public: 10841307117391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: Dentist
• Device Model Number: SPD3.2
• Device Catalogue Number: SPD3.2
• Device Lot Number: 95803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1