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 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a minor delay to get another bur and the procedure was completed successfully.

Manufacturer Narrative

Investigation results indicate that the fractured part potentially failed due to overload conditions.A review of the label, #2296-101-760 revision c, indicated that the label displays an icon which equates to "do not use excessive force" using this device.

Event Description

It was reported that during a tooth extraction procedure, the tip of the bur broke at the point where it connects to the shaft.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a minor delay to get another bur and the procedure was completed successfully.

• 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: 6855110
• MDR Text Key: 85639470
• Report Number: 0001811755-2017-01808
• 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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/11/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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