MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE UNIVERSAL DRIVER; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5400099000
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 2 events were reported for this quarter.Product return status: 2 devices were received for evaluation.Evaluation status: 2 device evaluations are in progress.Additional information: there were no remedial actions taken.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was shedding metal debris.The 2 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: corrected data: 2 previously reported events are included in this follow-up record.  evaluation status: 2 reported events were not confirmed during testing; the devices were found to be within specifications.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device was shedding metal debris.2 events had no patient involvement; no patient impact.

• Brand Name: CORE UNIVERSAL DRIVER
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7715289
• Report Number: 0001811755-2018-01368
• Device Sequence Number: 16548822
• Product Code: ERL
• UDI-Device Identifier: 04546540401977
• UDI-Public: 04546540401977
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 5400099000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1