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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES Back to Search Results
Model Number 5100060001
Device Problem Failure to Auto Stop (2938)
Patient Problem Rupture (2208)
Event Date 12/29/2022
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 craniotomy, the perforator bit did not disengage at the desired time.It was also reported that this lacerated the dura and the surface of the brain.It was further reported that there was no medical intervention, surgical delay and the procedure was completed successfully.
 
Event Description
It was reported that during a craniotomy, the perforator bit did not disengage at the desired time.It was also reported that this lacerated the dura and the surface of the brain.It was further reported that there was no medical intervention, surgical delay and the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
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Brand Name
ZYPHR DISP CRAN PERF LRG 14/11
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
Manufacturer Contact
una barry
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
EI   NA
214532900
MDR Report Key16237555
MDR Text Key308064003
Report Number3015967359-2023-00092
Device Sequence Number1
Product Code HBF
UDI-Device Identifier04546540716224
UDI-Public04546540716224
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 Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100060001
Device Catalogue Number5100060001
Device Lot Number22311067
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2022
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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