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

Model Number SPD3.2

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Event 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
• Type of Device: POWERED BONE DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7406570
• MDR Text Key: 105293474
• Report Number: 3001617766-2018-00057
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307117391
• UDI-Public: 10841307117391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1