MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM MULTI-FLUTE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820110020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not returned.
Event or Problem Description
It was reported that the shaft of the bur broke.No further information was provided.
Event or Problem Description
It was reported that the shaft of the bur broke.No further information was provided.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.

• Brand Name: 2.0MM MULTI-FLUTE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8687094
• Report Number: 0001811755-2019-01944
• Device Sequence Number: 14189993
• Product Code: HBE
• UDI-Device Identifier: 07613327294699
• UDI-Public: 07613327294699
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 5820110020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1