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 PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES
  • 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 PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2015
Event Type  malfunction  
Event Description
It was reported that during a cranial procedure, while using perforator bit for cranial entry, the perforator bit allegedly continued to drill beyond level expected by consultant.It was further reported that there was no adverse consequences as a result of the event.The procedure was completed successfully.
 
Event Description
It was reported that during a cranial procedure, while using perforator bit for cranial entry, the perforator bit allegedly continued to drill beyond level expected by consultant.It was further reported that there was no adverse consequences as a result of the event.The procedure was completed successfully.
 
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not made available to manufacturer.
 
Manufacturer Narrative
The device subject to this event was not available to stryker.Device history records were reviewed and all specifications were found to have been met.The root cause could not be determined as conditions of use the device were not made available and the device was not returned.The quality investigation is complete.Other device disposed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERFORATOR BIT LARGE 14/11MM
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key4574694
MDR Text Key5475996
Report Number0001811755-2015-00791
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/01/2015
Device Catalogue Number5100060001
Device Lot Number14306027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age19 YR
-
-