MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.2MM CROSS-CUT FISSURE CARBIDE BUR; BUR, DENTAL

Catalog Number	2296100212
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that the bur broke during a molar removal.It was further reported that the broken piece was retrieved from the patient.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that the bur broke during a molar removal.It was further reported that the broken piece was retrieved from the patient.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the bur broke as a result of being incorrectly loaded into the attachment.The instructions for use (ifu) of handpieces associated with this device provides detailed instructions for loading the cutting accessories and warn the user against this type of use: "warning: make sure the safety line on the cutting accessory is not visible after the shield is installed.Failure to comply may allow the cutting accessory to eject from the handpiece or bend.The quality investigation is complete.

• Brand Name: 1.2MM CROSS-CUT FISSURE CARBIDE BUR
• Common Device Name: BUR, DENTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8629557
• Report Number: 0001811755-2019-01775
• Device Sequence Number: 2308346
• Product Code: EJL
• UDI-Device Identifier: 04546540045874
• UDI-Public: 04546540045874
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 2296100212
• Device Lot Number: 17117017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1