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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Model Number 5400007000
Device Problem Device Remains Activated (1525)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2022
Event Type  malfunction  
Event Description
This report summarizes 2 malfunction events in which the device had run-on.2 events had patient involvement; no patient impact.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Additional information: 2 devices were not labeled for single-use.2 devices were reprocessed or reused.
 
Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 2 previously reported events are included in this follow-up record.Product return status: 2 devices were received.Additional information: 2 devices were not reprocessed or reused.
 
Event Description
This report summarizes 2 malfunction events in which the device had run-on.2 events had patient involvement; no patient impact.
 
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Brand Name
NSE FOOTSWITCH
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
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 Key15666714
MDR Text Key306937125
Report Number3015967359-2022-02148
Device Sequence Number1
Product Code DZJ
UDI-Device Identifier07613154879205
UDI-Public07613154879205
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/30/2023
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 Number5400007000
Device Catalogue Number5400007000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/30/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received09/30/2022
Supplement Dates FDA Received01/30/2023
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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