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

Catalog Number	5400037000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: one event was reported for this quarter.Product return status: one device was received for evaluation.Evaluation status: one device evaluation is 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 1 malfunction event in which the device was reportedly leaking.One event had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).  supplemental rationale: 1 previously reported event is included in this follow-up record.  product return status: 1 device was received for evaluation.  evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by widespread corrosion.  additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reportedly leaking.1 event had no patient involvement; no patient impact.

• Brand Name: CORE RECIP SAW
• 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: 7715240
• Report Number: 0001811755-2018-01358
• Device Sequence Number: 16424173
• Product Code: ERL
• UDI-Device Identifier: 04546540401960
• UDI-Public: 04546540401960
• 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,Followup
• Report Date (Section B): 12/04/2018

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: 5400037000
• 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: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1