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

Catalog Number	SPD3.2
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), during receiving inspection, the (b)(6) distributor found a lack of matted laser marking to show 18 mm depth on the spd3.2 powered dental drill.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.There was no adverse patient event associated with this malfunction.

• Brand Name: SWISH¿ STRAIGHT DRILL (6-16MML)
• Common Device Name: DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 7879236
• Report Number: 3001617766-2018-00227
• Device Sequence Number: 192274
• 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
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: Other
• Device Expiration Date: 03/24/2020
• Device Catalogue Number: SPD3.2
• Device Lot Number: 61723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1