MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.5MM X 10.0MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820071015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2019
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 during a craniotomy procedure, the bur broke.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 using a back-up bur.
Additional Manufacturer Narrative
Investigation results indicate that he most likely cause of breakage was lack of irrigation combined with excessive force and/or the application of a bending moment during use.A review of the label, #5820-103-702 revision aa, the label indicates by way of an expandable label 0036-902-000 revision b icon "do not use excessive force".The associated devices ifu for use was reviewed and contain 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 during a craniotomy procedure, the bur broke.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 using a back-up bur.

• Brand Name: 1.5MM X 10.0MM 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: 8905775
• Report Number: 0001811755-2019-02720
• Device Sequence Number: 19432198
• Product Code: HBE
• UDI-Device Identifier: 04546540467690
• UDI-Public: 04546540467690
• 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): 10/14/2019

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 Catalogue Number: 5820071015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1