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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 Problems Material Disintegration (1177); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2022
Event Type  malfunction  
Event Description
It was reported that during a cranial procedure, the perforator bit was involved with an event resulting in what appeared to be metal shavings.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and the procedure was completed successfully.
 
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.
 
Event Description
It was reported that during a cranial procedure, the perforator bit was involved with an event resulting in what appeared to be metal shavings.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was no surgical delay and 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 Key15040544
MDR Text Key296062712
Report Number3015967359-2022-01310
Device Sequence Number1
Product Code HBF
UDI-Device Identifier04546540716224
UDI-Public04546540716224
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 11/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5100060001
Device Catalogue Number5100060001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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