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

Catalog Number	5407FA1015SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting information if device is available for return.
Event or Problem Description
It was reported that during a surgical procedure, the router broke.A delay of unknown duration was reported.No further information was provided.
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.The quality investigation is complete.Device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the router broke.A delay of unknown duration was reported.No further information was provided.

• Brand Name: 1.5MM SPIRAL ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8727346
• Report Number: 0001811755-2019-02103
• Device Sequence Number: 2021835
• Product Code: HBE
• UDI-Device Identifier: 07613327096705
• UDI-Public: 07613327096705
• Combination Product (Y/N): N
• PMA/510(K) Number: K143399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 5407FA1015SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1