FDA.reportPublic FDA data

MAUDE MDR 2466128

MDR report key
2466128
Report number
9616696-2012-00030
Event key
0
Event type
3
Date of event
2012-01-11
Date received
2012-02-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
UNA BARRY
Address
CARRIGTWOHILL BUSINESS & TECHNOLOGY PARK CARRIGTWOHILL, CORK EI
Phone
214-214-2145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSCILLATING AND SAGITTAL BLADESTRYKER IRELAND LTD.DWH2296033521UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-02-090

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

N

Patient 1

THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; IT WAS DISCARDED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.