STERNUM BLADE 0298097100

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 2013-10-29 for STERNUM BLADE 0298097100 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[4186005] It was reported that the blade broke during a procedure. The case was completed successfully without any procedure delay. There was no medical treatment or intervention required and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[11440327] The evaluation concluded that the blade fractured in an area of high stress concentration. Overloading of the blade or an induced bending motion could have contributed to this type of fracture.
Patient Sequence No: 1, Text Type: N, H10


[21811036] It was reported that the blade broke during a procedure. The case was completed successfully without any procedure delay. There was no medical treatment or intervention required and no adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001811755-2013-02661
MDR Report Key3435546
Report Source07
Date Received2013-10-29
Date of Report2013-10-04
Date of Event2013-10-02
Date Mfgr Received2014-01-22
Device Manufacturer Date2013-04-03
Date Added to Maude2013-10-29
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 ContactMR. DERVILLIA MURPHY
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer PostalNA
Manufacturer Phone214532900
Manufacturer G1STRYKER INSTRUMENTS-IRELAND
Manufacturer StreetINSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK
Manufacturer CityCARRIGTWOHILL NA
Manufacturer Postal CodeNA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTERNUM BLADE
Generic NameBLADE, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2013-10-29
Returned To Mfg2013-10-17
Catalog Number0298097100
Lot Number13093017
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2013-10-29

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