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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 08/28/2013
Event Type  Injury  
Event Description
It was initially reported that the surgeon observed that dura was stuck to the underside of the bone.The surgeon reported that the patient was older and sometimes dura can stick in older patients.It was subsequently reported via a medwatch report that during a cranial procedure, the dura was completely adherent to the bone and therefore could not be separated.It had become incorporated into the hyperostotic inner table of the skull.It was also reported that the dura was completely intimate with the bone and could not be separated.The dura was repaired and the wound was copiously irrigated with antibiotic solution and the temporalis muscle and fascia were closed using interrupted sutures.It was further reported the patient was able to move all extremities and follow simple commands and take to the intensive case unit in stable neurologic and cardiovascular condition.No additional adverse consequences reported.
 
Event Description
It was initially reported that the surgeon observed that dura was stuck to the underside of the bone.The surgeon reported that the patient was older and sometimes dura can stick in older patients.It was subsequently reported via a medwatch report that during a cranial procedure, the dura was completely adherent to the bone and therefore could not be separated.It had become incorporated into the hyperostotic inner table of the skull.It was also reported that the dura was completely intimate with the bone and could not be separated.The dura was repaired and the wound was copiously irrigated with antibiotic solution and the temporalis muscle and fascia were closed using interrupted sutures.It was further reported the patient was able to move all extremities and follow simple commands and take to the intensive case unit in stable neurologic and cardiovascular condition.No additional adverse consequences reported.
 
Manufacturer Narrative
New information became available on this event via medwatch (b)(4).A follow up report will be filed once the quality investigation is complete.
 
Manufacturer Narrative
Quality investigation is now 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 Key3575887
MDR Text Key4144642
Report Number0001811755-2014-00165
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 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/01/2014
Device Catalogue Number5100060001
Device Lot Number13199027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received03/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5400130000, (B)(4); 5400210060, (B)(4); 5400050000, SN UKN
Patient Outcome(s) Other;
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