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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 Problems Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abrasion (1689)
Event Date 12/29/2014
Event Type  Injury  
Event Description
It was reported that during an aneurysm procedure the perforator appeared to be running for longer than usual.The surgeon voluntarily stopped the perforator and upon removal of it from the site it was noticed that dura was breached.The procedure was completed by drilling part of the way in 2 holes and then connecting the holes from the other two holes that had drilled right through the dura.There was no surgical delay reported as a result of this event.The full patient impact is unknown at this time.It was reported that the patient was placed on anti-seizure medication for 3 months as a result.
 
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 the manufacturer.
 
Event Description
It was reported that during an aneurysm procedure the perforator appeared to be running for longer than usual.The surgeon voluntarily stopped the perforator and upon removal of it from the site it was noticed that dura was breached.The procedure was completed by drilling part of the way in 2 holes and then connecting the holes from the other two holes that had drilled right through the dura.There was no surgical delay reported as a result of this event.The full patient impact is unknown at this time.It was reported that the patient was placed on anti-seizure medication for 3 months as a result.
 
Manufacturer Narrative
The device was returned for evaluation and functional testing of the disengagement mechanism confirmed that the mechanism functioned as intended.The customer account additionally returned two unused perforators (perforator bit large, p/n 5100-060-001) from the same lot 14279017 and functional testing of the disengagement mechanism confirmed that the mechanism functioned as intended.The following was reported and could potentially contribute to the reported event: the perforator was used in the temporal region of the skull.The ifu (instruction for use) has a warning which states ¿caution should be taken to avoid use in skulls/skull areas that have thin bone (e.G.Temporal and suboccipital areas).Failure to comply may result in serious patient injury or death¿.Device history records were reviewed and all specifications were found to have been met.The quality investigation is 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 Key4444263
MDR Text Key5314769
Report Number0001811755-2015-00257
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 12/29/2014
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 Catalogue Number5100060001
Device Lot Number3151001142790173Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2015
Initial Date FDA Received01/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/16/2015
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
Patient Outcome(s) Other;
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