MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM ROUND SOLID CARBIDE BUR LONG; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	5300020509
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke and hit a healthcare staff in the face with no adverse consequences.It was further reported that the event caused a two minute delay.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Additional procedure information added.Initial reporter details updated.The quality investigation is complete.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke and hit a healthcare staff in the face with no adverse consequences.It was further reported that the event caused a two minute delay.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.It was subsequently reported that the procedure was a triple arthrodesis.

• Brand Name: 3.0MM ROUND SOLID CARBIDE BUR LONG
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9475370
• Report Number: 0001811755-2019-04073
• Device Sequence Number: 2259172
• Product Code: GFF
• UDI-Device Identifier: 07613153000969
• UDI-Public: 07613153000969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 10/16/2024
• Device Model Number: 5300020509
• Device Catalogue Number: 5300020509
• Device Lot Number: 19289017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1