MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5.5MM OVAL SOLID CARBIDE BUR LONG; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	5300020903
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/13/2019
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 after a surgical procedure, the bur broke which the scrub technician tried to remove the bur while still locked in the attachment.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
H6: the quality investigation is complete.H3 other text : device was discarded.
Event or Problem Description
It was reported that after a surgical procedure, the bur broke which the scrub technician tried to remove the bur while still locked in the attachment.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: 5.5MM OVAL 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: 9175698
• Report Number: 0001811755-2019-03210
• Device Sequence Number: 19536025
• Product Code: GFF
• UDI-Device Identifier: 07613153001140
• UDI-Public: 07613153001140
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 03/01/2024
• Device Catalogue Number: 5300020903
• Device Lot Number: 19086017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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: 5100015270 LOT19212; 5100015270 LOT19212