MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.1MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0277010421
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
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 during a wisdom tooth extraction procedure, the bur broke at the tip.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a backup bur.
Additional Manufacturer Narrative
Investigation results indicate that the bur was subjected to an excessive bending moment, or experienced shock loading due to contact with metal, which overloaded the bur and caused it to fracture.The associated devices ifu's state that the device and associated handpieces are "intended for surgical procedures involving cutting bone and hard tissue".The quality investigation is complete.
Event or Problem Description
It was reported that during a wisdom tooth extraction procedure, the bur broke at the tip.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a backup bur.

• Brand Name: 2.1MM CROSS-CUT FISSURE CARBIDE BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8290153
• Report Number: 0001811755-2019-00446
• Device Sequence Number: 1912266
• Product Code: GFF
• UDI-Device Identifier: 04546540050625
• UDI-Public: 04546540050625
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 05/01/2023
• Device Catalogue Number: 0277010421
• Device Lot Number: 18122017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1