MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.1MM X 6.0MM STRAIGHT ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820070011
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that the bur broke during a craniotomy.It was also reported that the doctor left the piece inside the patient.It was further reported that there was no medical intervention as a result of this event.It was also reported that the procedure was completed successfully with a spare bur.No further information was provided.
Additional Manufacturer Narrative
Investigation results indicate that the most likely cause of breakage is localised excessive force applied near the tip of the router.The associated devices ifu for use with this device contains the following warning; "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory" the quality investigation is complete.
Event or Problem Description
It was reported that the bur broke during a craniotomy.It was also reported that the doctor left the piece inside the patient.It was further reported that there was no medical intervention as a result of this event.It was also reported that the procedure was completed successfully with a spare bur.No further information was provided.

• Brand Name: 1.1MM X 6.0MM STRAIGHT ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9220803
• Report Number: 0001811755-2019-03284
• Device Sequence Number: 2734347
• Product Code: HBE
• UDI-Device Identifier: 04546540362391
• UDI-Public: 04546540362391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: 06/01/2024
• Device Catalogue Number: 5820070011
• Device Lot Number: 19176017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1