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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Catalog Number 5100060001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2015
Event Type  malfunction  
Event Description
It was reported that during a cranial procedure, the perforator bit did not work.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and the procedure was completed successfully.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not work.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and the procedure was completed successfully.
 
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Device not yet returned to manufacturer.
 
Manufacturer Narrative
The definitive root cause could not be determined, investigation results confirm the device functioned as intended.A potential cause for this event is insufficient force applied to the perforator.
 
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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 Key4764290
MDR Text Key5782165
Report Number0001811755-2015-01709
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2015
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 Manufacturer06/09/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received07/14/2015
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
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