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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRODRILL STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRODRILL STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problems No Patient Involvement (2645); No Information (3190); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 7 events were reported for this quarter. Product return status: 3 devices were received. 4 device investigation types have not yet been determined. Event confirmation status: 2 reported events were confirmed. 1 reported event was not confirmed. Evaluation results: 2 devices were found to be affected by bearing corrosion. Additional information: 7 devices were not labeled for single-use. 7 devices were not reprocessed or reused.
 
Event Description
This report summarizes 7 malfunction events in which the device reportedly overheated. 6 events had no patient involvement; no patient impact. 1 event had no information received.
 
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Brand NameMICRODRILL STRAIGHT ATTACHMENT
Type of DeviceUNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key9998440
MDR Text Key191039345
Report Number0001811755-2020-01199
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported7
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5100015250
Device Catalogue Number5100015250
Device Lot NumberVMSR
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 Received03/31/2020
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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