MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5407FA3030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
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 during a craniotomy with tumour resection, the router broke at the cutting end.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
The quality investigation is complete.
Event or Problem Description
It was reported that during a craniotomy with tumour resection, the router broke at the cutting end.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: 3.0MM TAPERED ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7395357
• Report Number: 0001811755-2018-00571
• Device Sequence Number: 61533
• Product Code: HBE
• UDI-Device Identifier: 07613327096736
• UDI-Public: (01)07613327096736
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K143399
• 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): 05/09/2018

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: 12/01/2020
• Device Model Number: 5407FA3030
• Device Catalogue Number: 5407FA3030
• Device Lot Number: 17341017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1