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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 Abrasion (1689)
Event Date 09/02/2021
Event Type  Injury  
Event Description
It was reported via health canada, reference # (b)(4), that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that this caused a dural tear.No further information was provided.
 
Manufacturer Narrative
The quality investigation is complete.Device not returned.
 
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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 Key15562687
MDR Text Key301351023
Report Number3015967359-2022-01873
Device Sequence Number1
Product Code HBF
UDI-Device Identifier04546540716224
UDI-Public04546540716224
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/07/2022
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 Expiration Date05/01/2024
Device Model Number5100060001
Device Catalogue Number5100060001
Device Lot Number21148057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/12/2022
Initial Date FDA Received10/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2021
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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