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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 Failure to Auto Stop (2938)
Patient Problem Abrasion (1689)
Event Date 12/09/2013
Event Type  Injury  
Event Description
It was reported that during a cranial procedure the perforator did not disengage and the inner and outer parts of the perforator did not separate.The customer further reported that the perforator completely breached the inner table of the skull resulting in entry to the sinus.
 
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return.
 
Event Description
It was reported that during a cranial procedure the perforator did not disengage and the inner and outer parts of the perforator did not separate.The customer further reported that the perforator completely breached the inner table of the skull resulting in entry to the sinus.
 
Manufacturer Narrative
Device returned evaluation complete.
 
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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 Key3553036
MDR Text Key3978058
Report Number0001811755-2014-00029
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2014
Device Catalogue Number5100060001
Device Lot Number13280027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2013
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 Outcome(s) Other;
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