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	05/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device was discarded.
Event or Problem Description
It was reported that during a surgical procedure, the router broke while tacking up holes.It was also reported that there was a one minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported event, for break, was not confirmed as the device was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that during a surgical procedure, the router broke while tacking up holes.It was also reported that there was a one minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• 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: 10140353
• Report Number: 0001811755-2020-01416
• Device Sequence Number: 2256311
• Product Code: HBE
• UDI-Device Identifier: 07613327096781
• UDI-Public: 07613327096781
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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 Expiration Date: 02/01/2021
• Device Model Number: 5407070011
• Device Catalogue Number: 5407070011
• Device Lot Number: 18047017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1