MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.7MM X 25.0MM D-59 TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5120071059
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
Event or Problem Description
It was reported that during an osteotomy in brain surgery craniotomy, the router broke.No further information was provided.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during an osteotomy in brain surgery craniotomy, the router broke.No further information was provided.

• Brand Name: 1.7MM X 25.0MM D-59 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: 10196786
• Report Number: 0001811755-2020-01553
• Device Sequence Number: 2464788
• Product Code: HBE
• UDI-Device Identifier: 04546540618214
• UDI-Public: 04546540618214
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 5120071059
• Device Catalogue Number: 5120071059
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1