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

Model Number	5407070011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, the router broke in the attachment.It was also reported 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 reported event, for router breakage, was not confirmed as the router was not returned for evaluation.Without the router, the root cause cannot be determined.Device not received by stryker.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, the router broke in the attachment.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, the router broke in the attachment.It was also reported 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 reported router involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The router was evaluated by product engineering who concluded that the break location is 0.0078¿ from the shoulder between the flute and minor shank (0.7972¿ from the tip of the router).This location is a high stress location on the part.Breakage at this location is likely as a result of excessive force/bending applied to the head of the router.The router breakage is likely as a result of excessive force applied to the router head.The quality investigation is complete.

• Brand Name: 1.1MM 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: 9770632
• Report Number: 0001811755-2020-00570
• Device Sequence Number: 19476424
• Product Code: HBE
• UDI-Device Identifier: 07613327096781
• UDI-Public: 07613327096781
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 05/11/2020

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: 5407070011
• Device Catalogue Number: 5407070011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 05/08/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/06/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1