MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL

Catalog Number 2296101316

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded.

Event Description

It was reported that during a tooth extraction procedure, three burs broke, it was also reported that there was a slight delay while getting a replacement bur.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the second bur that broke.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that during a tooth extraction procedure, three burs broke, it was also reported that there was a slight delay while getting a replacement bur.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.This report is for the second bur that broke.

• Brand Name: 1.6MM CROSS-CUT FISSURE CARBIDE BUR
• Type of Device: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6816412
• MDR Text Key: 83488687
• Report Number: 0001811755-2017-01773
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: 4546540046239
• UDI-Public: (01)4546540046239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 2296101316
• Device Lot Number: 17118017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1