MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THE MILL DISPOSABLE- FINE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	5400702000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
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.Reported events: 4 events were reported for this quarter.Product return status: 3 devices were available for evaluation but have not yet been received.1 device was not available to stryker for evaluation.Additional information: 4 devices are labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device had a white substance or dust in the packaging.4 events had 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: 4 total events were initially reported.3 previously reported events are included in this follow-up record.  product return status 3 devices were received.  evaluation status confirmed 3 reported events were confirmed during testing.-  devices were found to be affected by excessive vibration/shaking during shipping and handling.  additional information 4 devices were labeled for single-use.4 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 4 malfunction events in which the device had a white substance or dust in the packaging.4 events had patient involvement; no patient impact.

• Brand Name: THE MILL DISPOSABLE- FINE
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8014196
• Report Number: 0001811755-2018-01949
• Device Sequence Number: 13811670
• Product Code: HWE
• UDI-Device Identifier: 34546540604119
• UDI-Public: 34546540604119
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 4
• 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): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 5400702000
• Device Lot Number: E2015055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1