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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-KALAMAZOO MICRODRILL SERIES STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 06/02/2018
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4). Reported events: 36 events were reported for this quarter. Product return status: 35 devices were received for evaluation. 1 device was available for evaluation but has not yet been received. Evaluation status: 24 events were confirmed during testing. 16 devices were found to be affected by corrosion. 4 devices were found to be affected by worn components. 2 devices were found to be affected by worn components and corrosion. 2 devices were found to be affected by shattered bearings. 3 events were not confirmed during testing; however: 1 device was found to be affected by corrosion and debris. 2 devices were found to be affected by corrosion. 8 device evaluations are in progress. Additional information: 36 devices were not labeled for single-use. 36 devices were not reprocessed and reused.
 
Event Description
This report summarizes 36 malfunction events in which the device reportedly overheated. 31 events had no patient involvement; no patient impact. 1 event had no known patient involvement or patient impact. 1 event had patient involvement; no patient impact. 3 events had the patient receive a burn.
 
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Brand NameMICRODRILL SERIES STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8014870
MDR Text Key125492449
Report Number0001811755-2018-02113
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported36
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5100015250
Device Lot NumberE2015055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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