MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.1MM SHANNON SIDE CUTTING; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820101021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 e2015055.1 event was reported for this quarter.1 event suggests the bur broke as a result of overload conditions.Additional information: 1 device is labelled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device broke during a lower jaw osteotomy.There was patient involvement.There was no patient impact.

• Brand Name: 2.1MM SHANNON SIDE CUTTING
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8001790
• Report Number: 0001811755-2018-01782
• Device Sequence Number: 16492662
• Product Code: HBE
• UDI-Device Identifier: 04546540467737
• UDI-Public: 04546540467737
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• 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: 5820101021
• 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