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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
Catalog Number 5100015250
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2023
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.8 events were reported for this quarter.Product return status.4 devices were received.1 device was not available for evaluation.3 device investigation types have not yet been determined.Additional information.8 devices were not labeled for single-use.8 devices were not reprocessed or reused.
 
Event Description
This report summarizes 8 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event 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 8 previously reported events are included in this follow-up record.Product return status 5 devices were received.1 device was not available for evaluation.2 device investigation types have not yet been determined.
 
Event Description
This report summarizes 8 malfunction events in which the device reportedly overheated.- 6 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.- 1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.
 
Event Description
This report summarizes 8 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event 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: 8 previously reported events are included in this follow-up record.Product return status: 5 devices were received.3 devices were not available for evaluation.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 8 previously reported events are included in this follow-up record.Product return status: 5 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.
 
Event Description
This report summarizes 8 malfunction events in which the device reportedly overheated.6 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.1 event 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 Key17993208
MDR Text Key327182559
Report Number3015967359-2023-02349
Device Sequence Number1
Product Code EIA
UDI-Device Identifier04546540380272
UDI-Public04546540380272
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported8
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number5100015250
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/30/2023
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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