CORE INTRA-ORAL BLADE 5400031034

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-17 for CORE INTRA-ORAL BLADE 5400031034 manufactured by Stryker Ireland Ltd..

Event Text Entries

[1598066] It was reported that the blade broke at the arbor during an oral surgical procedure. It was further reported that the procedure was successfully completed. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


[8608036] The blade subject to this mdr was returned for eval. It was visually confirmed that the blade broke at the joint to the arbor. Measurements carried out on the blade confirmed that all features conformed to required specification. A documentation review confirmed that no issues were identified which may have contributed to this event. The root cause for the breakage is undetermined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9616696-2010-00250
MDR Report Key1757122
Report Source07
Date Received2010-06-17
Date of Report2010-05-25
Date of Event2010-05-25
Date Mfgr Received2010-05-25
Device Manufacturer Date2010-03-01
Date Added to Maude2011-03-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactUNA BARRY
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Manufacturer Phone214532963
Manufacturer G1STRYKER IRELAND LTD.
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCORE INTRA-ORAL BLADE
Generic NameSAW BLADES AND ACCESSORIES
Product CodeDZH
Date Received2010-06-17
Returned To Mfg2010-06-14
Catalog Number5400031034
Lot Number10060017
Device Expiration Date2015-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER IRELAND LTD.
Manufacturer AddressCARRIGTWOHILL, CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2010-06-17

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