• 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 SYSTEM 7 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

  • 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 SYSTEM 7 SINGLE TRIGGER ROTARY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7203000000
Device Problem Unintended Power Up (1162)
Patient Problem No Patient Involvement (2645)
Event Date 07/15/2016
Event Type  malfunction  
Event Description
It was reported that during equipment testing conducted by a manufacturer field service technician that the handpiece would run without the trigger being pulled. No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYSTEM 7 SINGLE TRIGGER ROTARY
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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 Key5871572
MDR Text Key51949959
Report Number0001811755-2016-01809
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number7203000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-