MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SWISH STRAIGHT DRILL (6-16MML)

Model Number	SWISH¿ STRAIGHT DRILL (6-16MML)
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4) distributor found during incoming inspection, a lack of laser markings.Distributor received the correct part, however they received the previous revision of this drill which is now marketed with the new groovings and laser markings.Distributor requested replacements with the newest revisions.

• Brand Name: SWISH STRAIGHT DRILL (6-16MML)
• Common Device Name: STRAIGHT DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7485710
• Report Number: 3001617766-2018-00088
• Device Sequence Number: 1544476
• 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): 05/03/2018

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: SWISH¿ STRAIGHT DRILL (6-16MML)
• Device Catalogue Number: SPD3.2
• Device Lot Number: 99859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1