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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 Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2022
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: 9 events were reported for this quarter.Product return status: 4 devices were received.5 device investigation types have not yet been determined.Additional information: 9 devices were not labeled for single-use.9 devices were not reprocessed or reused.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.4 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 9 previously reported events are included in this follow-up record.Product return status: 5 devices were received.2 devices were not available for evaluation.2 device investigation types have not yet been determined.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale 9 previously reported events are included in this follow-up record.Product return status 5 devices were received.3 devices were not available for evaluation.1 device investigation type has not yet been determined.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.- 4 events had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.- 3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: h6, h10.9 previously reported events are included in this follow-up record.Product return status: 5 devices were received.4 devices were not available for evaluation.
 
Event Description
This report summarizes 9 malfunction events in which the device reportedly overheated.4 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.3 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
 
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Brand Name
MICRODRILL STRAIGHT ATTACHMENT
Type of Device
UNIT, 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
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key16262011
MDR Text Key308858142
Report Number3015967359-2023-00295
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported9
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 10/24/2023
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
Device Model Number5100015250
Device Catalogue Number5100015250
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/31/2022
Initial Date FDA Received01/29/2023
Supplement Dates Manufacturer Received12/31/2022
12/31/2022
12/31/2022
Supplement Dates FDA Received04/25/2023
07/27/2023
10/24/2023
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
Patient Sequence Number1
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