FDA.reportPublic FDA data

MAUDE MDR 3902009

MDR report key
3902009
Report number
0001811755-2014-02315
Event key
0
Event type
3
Date of event
2014-06-09
Date received
2014-06-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. DERVILLIA MURPHY
Address
INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK CARRIGTWOHILL NA
Phone
214-214-2145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STERNUM BLADEBLADE, SAW, SURGICAL, CARDIOVASCULARSTRYKER INSTRUMENTS-KALAMAZOODWH0298097100UNKNOWNY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-3001. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

N

Patient 1

THE DEVICE WAS RETURNED FOR EVALUATION. THE QUALITY INVESTIGATION IS COMPLETE.

D

Patient 1

IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS A 5 MINUTE DELAY AS A RESULT. AN X-RAY WAS TAKEN TO ENSURE NO PIECE WAS LEFT BEHIND. THERE WAS NO PATIENT IMPACT OR ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

N

Patient 1

THE DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT YET RETURNED TO MANUFACTURER.