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U.S. Department of Health and Human Services

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

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STRYKER INSTRUMENTS-KALAMAZOO THE MILL DISPOSABLE- MEDIUM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 5400701000
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Eight events were reported for this quarter. Seven devices were not available to stryker for evaluation. One device was available for evaluation but has not yet been received. There were no remedial actions taken. This device is labeled for single-use.
 
Event Description
This report summarizes 8 malfunction events in which the device had a white substance or dust in the packaging. There was patient involvement; no patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.     supplemental rationale corrected data: 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 a missing label or original packaging.   additional information: 1 device is not labeled for single-use. 1 device was not reprocessed and reused.
 
Event Description
This report summarizes 8 malfunction events in which the device had a white substance or dust in the packaging. There was patient involvement; no patient impact.
 
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Brand NameTHE MILL DISPOSABLE- MEDIUM
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7467050
MDR Text Key107193866
Report Number0001811755-2018-00871
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported8
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5400701000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2017
Is This a Reprocessed and Reused Single-Use Device? No

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