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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD CABLE; UNIT, OPERATIVE DENTAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STANDARD CABLE; UNIT, OPERATIVE DENTAL Back to Search Results
Model Number 5100004000
Medical Device Problem Code Unintended Power Up (1162)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status 1 device was received.: additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device ran without user activation.1 event had no patient involvement; no patient impact.
 
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Brand Name
STANDARD CABLE
Common Device Name
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key11728518
Report Number3015967359-2021-00532
Device Sequence Number3018157
Product Code EIA
UDI-Device Identifier04546540970275
UDI-Public04546540970275
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2021
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
Operator of Device No Information
Device Model Number5100004000
Device Catalogue Number5100004000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/01/2021
Initial Report FDA Received Date04/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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