MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 25.4MM X 0.8MM METAL CUTTING DIAMOND DISC; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5120130250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.2 events were reported for this quarter.2 events suggests the burs broke as a result of overload conditions.Additional information: 2 devices were labelled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device broke during a surgical procedure.There was patient involvement.There was no patient impact.

• Brand Name: 25.4MM X 0.8MM METAL CUTTING DIAMOND DISC
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8001706
• Report Number: 0001811755-2018-01781
• Device Sequence Number: 1434019
• Product Code: HBE
• UDI-Device Identifier: 04546540078247
• UDI-Public: 04546540078247
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/24/2018

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: No Information
• Device Catalogue Number: 5120130250
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1