STERNUM BLADE 0298097100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-08-17 for STERNUM BLADE 0298097100 manufactured by Stryker Ireland Ltd.

Event Text Entries

[1379531] It was reported that during a valve replacement procedure, the sternum blade broke. It was also reported that the broken pieces were retrieved using a forceps and that the surgeon has no concerns on pieces being left behind. It was further reported that there were no adverse consequences for the pt and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


[8752401] The blade subject to this mdr was returned for eval. It was visually confirmed that the blade was broken just above the mount section. The returned blade was measured where possible and all critical specifications were met. The mfg records were reviewed, no issues were identified which may have contributed to this event. The root cause is undetermined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9616696-2010-00266
MDR Report Key1819363
Report Source01,06
Date Received2010-08-17
Date of Report2010-07-21
Date of Event2010-07-19
Date Mfgr Received2010-07-21
Device Manufacturer Date2010-04-26
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 Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactUNA BERRY
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 NameSTERNUM BLADE
Generic NameSAW BLADES & ACCESSORIES
Product CodeDWH
Date Received2010-08-17
Returned To Mfg2010-08-06
Catalog Number0298097100
Lot Number10118017
Device Expiration Date2015-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER IRELAND LTD
Manufacturer AddressCARRIGTWOHILL, CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-17

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