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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 01/12/2015
Event Type  Injury  
Event Description
It was reported that during biopsy surgery the perforator continued to drill without stopping before hitting the dura.It was reported that it took away 50% of the dura in the area of the cut.It was further reported that the event caused some bleeding which was stemmed quickly by the engineer.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.
 
Event Description
It was reported that during biopsy surgery the perforator continued to drill without stopping before hitting the dura.It was reported that it took away 50% of the dura in the area of the cut.It was further reported that the event caused some bleeding which was stemmed quickly by the engineer.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.It was subsequently reported that nothing unusual was seen on any ct scans performed after the procedure.
 
Manufacturer Narrative
The device is not available for return.A follow up report will be filed once the quality investigation is complete.Device discarded by the customer.
 
Manufacturer Narrative
A review of the manufacturing records for the reported device has not revealed any discrepancies.The quality investigation is complete.Device discarded by customer.
 
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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 Key4444882
MDR Text Key5387591
Report Number0001811755-2015-00278
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 01/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2015
Device Catalogue Number5100060001
Device Lot Number14293047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/14/2015
Initial Date FDA Received01/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/27/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2014
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 Outcome(s) Other;
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