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

Catalog Number SPD3.2

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2017

Event Type  malfunction  

Event 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)
• Type of Device: DRILL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7879236
• MDR Text Key: 120712109
• Report Number: 3001617766-2018-00227
• 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
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1