MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.2MM ROUND BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	1608002011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
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 during a sports medicine surgical procedure, the bur broke at the notch.It was also reported that the bur fell out of the attachment.It was further reported that there were no adverse consequences or surgical delay due to this event.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to the product engineering group who concluded that the most likely cause of breakage is that the bur was not locked into the attachment when the handpiece was actuated.
Event or Problem Description
It was reported that during a sports medicine surgical procedure, the bur broke at the notch.It was also reported that the bur fell out of the attachment.It was further reported that there were no adverse consequences or surgical delay due to this event.It was also reported that the procedure was completed successfully.

• Brand Name: 3.2MM ROUND 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: 8351650
• Report Number: 0001811755-2019-00578
• Device Sequence Number: 207108
• Product Code: GFF
• UDI-Device Identifier: 04546540030504
• UDI-Public: 04546540030504
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 06/01/2023
• Device Catalogue Number: 1608002011
• Device Lot Number: 18171017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1