MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM MULTI-FLUTE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820110020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that the shaft of the bur broke during a spinal procedure.It was also reported that there was a few minutes delay to get a new bur and drill to remove tip.It was further reported that a x-ray was performed to confirm removal.It was also reported that the procedure was completed successfully.
Event or Problem Description
It was reported that the shaft of the bur broke during a spinal procedure.It was also reported that there was a few minutes delay to get a new bur and drill to remove tip.It was further reported that a x-ray was performed to confirm removal.It was also reported that the procedure was completed successfully.
Additional Manufacturer Narrative
The definitive root cause could not be determined.A photograph of the broken device was provided which confirmed the breakage.The quality investigation is complete.

• Brand Name: 2.0MM MULTI-FLUTE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8632289
• Report Number: 0001811755-2019-01777
• Device Sequence Number: 1941765
• Product Code: HBE
• UDI-Device Identifier: 07613327294699
• UDI-Public: 07613327294699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 04/01/2024
• Device Catalogue Number: 5820110020
• Device Lot Number: 19093017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1