Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-KALAMAZOO NSE FOOTSWITCH; DRIVER, WIRE, AND BONE DRILL, MANUAL Back to Search Results
Catalog Number 5400007000
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2016
Event Type  malfunction  
Event Description
The user facility reported that wires were exposed during testing.The user facility did not report any adverse events related to this event.
 
Manufacturer Narrative
Manufacturer report number 0001811755-2016-02773 was filed in error.Additional information regarding the event clarified that the customer did not experience a reportable event per 21 cfr 803:20.
 
Event Description
The user facility reported that wires were exposed during testing.The user facility did not report any adverse events related to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NSE FOOTSWITCH
Type of Device
DRIVER, WIRE, AND BONE DRILL, MANUAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6120056
MDR Text Key60628525
Report Number0001811755-2016-02773
Device Sequence Number1
Product Code DZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number5400007000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-