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 SYSTEM 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4208000000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 11/17/2014
Event Type  Injury  
Event Description
It was reported that during a surgical procedure at the user facility the patient's artery was nicked.The procedure was completed successfully.No further information was provided by the user facility; as such, any patient consequences or medical intervention are unknown.There was no reported malfunction of any medical device in use during this procedure.
 
Manufacturer Narrative
There was no reported malfunction of any medical device in use during this procedure.The device was not returned for analysis; it is not possible to determine the cause of the reported event without an evaluation of the device.Stryker is submitting this adverse event report due to the fact that the event was reported to stryker.If further information becomes available, a supplemental report will be submitted.The device was not returned for analysis.
 
Event Description
It was reported that during a surgical procedure at the user facility the patient's artery was nicked.The procedure was completed successfully.No further information was provided by the user facility; as such, any patient consequences or medical intervention are unknown.There was no reported malfunction of any medical device in use during this procedure.
 
Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYSTEM 5 SAGITTAL SAW
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key4326625
MDR Text Key5244085
Report Number0001811755-2014-04512
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,user facility
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4208000000
Was Device Available for Evaluation? No
Date Manufacturer Received11/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-