MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE CARBIDE BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0277010216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a procedure on the jawbone, the bur broke along the shaft.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.
Additional Manufacturer Narrative
Investigation results indicate that the bur was subjected to an excessive bending moment or contacted metal during use which caused it to fracture.The quality investigation is complete.
Event or Problem Description
It was reported that during a procedure on the jawbone, the bur broke along the shaft.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.

• Brand Name: 1.6MM 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: 8604666
• Report Number: 0001811755-2019-01665
• Device Sequence Number: 11520699
• Product Code: GFF
• UDI-Device Identifier: 04546540050502
• UDI-Public: 04546540050502
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: No Information
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 0277010216
• Device Lot Number: 18332017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5100015272 SN: UNKNOWN; 6400015000 SN: UNKNOWN; 5100015272 SN: UNKNOWN; 6400015000 SN: UNKNOWN