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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 03/20/2023
Event Type  Injury  
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional tear of the dura mater and the surgeon had to check for an associated frontal contusion.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
 
Manufacturer Narrative
H6: the quality investigation is complete.
 
Event Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional tear of the dura mater and the surgeon had to check for an associated frontal contusion.It was further reported that the procedure was completed successfully.
 
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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 Key16731682
MDR Text Key313205491
Report Number3015967359-2023-00727
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2023
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 Number22343017
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2022
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) Required Intervention;
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