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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, 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 02/27/2019
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Event Description
It was reported that during a cranial procedure, two perforator bits did not stop.This record addresses one of the perforator bits involved.It was also reported that there was an unintentional durotomy during a bur hole and the brain was slightly damaged as a result of this event.It was also reported that management of hemostasis was required.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
The perforator product reported involved with this event was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.
 
Event Description
It was reported that during a cranial procedure, two perforator bits did not stop.This record addresses one of the perforator bits involved.It was also reported that there was an unintentional durotomy during a bur hole and the brain was slightly damaged as a result of this event.It was also reported that management of hemostasis was required.It was further reported that the procedure was completed successfully.
 
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Brand Name
ZYPHR DISPOSABLE CRANIAL PERFORATOR, 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
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key8460293
MDR Text Key140176885
Report Number0001811755-2019-01003
Device Sequence Number1
Product Code HBF
UDI-Device Identifier04546540716224
UDI-Public04546540716224
Combination Product (y/n)N
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2019
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 NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2019
Initial Date FDA Received03/28/2019
Supplement Dates Manufacturer Received04/26/2019
Supplement Dates FDA Received05/14/2019
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 Age59 YR
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