MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0 ELITE RND DIAMND XTR CORSE; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820013140
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
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 during a surgical procedure, a bur broke at the cutting end.It was further reported a spare was used.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Initial reporter updated additional information provided on procedure type the device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that the during a spinal decompression surgical procedure, a bur broke at the cutting end.It was further reported a spare was used.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 4.0 ELITE RND DIAMND XTR CORSE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9475338
• Report Number: 0001811755-2019-04062
• Device Sequence Number: 14130150
• Product Code: HBE
• UDI-Device Identifier: 04546540374295
• UDI-Public: 04546540374295
• Combination Product (Y/N): N
• PMA/510(K) Number: K143320
• 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): 02/06/2020

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 Model Number: 5820013140
• Device Catalogue Number: 5820013140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1