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 Problems Use of Device Problem (1670); Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2015
Event Type  malfunction  
Event Description
It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.
 
Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
 
Manufacturer Narrative
The device was returned for evaluation and functional testing of the disengagement mechanism confirmed that the mechanism functioned as intended.The definitive root cause could not be determined and potentially failure to follow instructions caused or contributed to this event.
 
Event Description
It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.
 
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 Key4941706
MDR Text Key21558298
Report Number0001811755-2015-02733
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K032303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5100060001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/19/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-