FDA.reportPublic FDA data

MAUDE MDR 3667848

MDR report key
3667848
Report number
2520274-2014-10173
Event key
0
Event type
3
Date of event
2014-01-28
Date received
2014-03-07
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
LINDA PLEWS
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WIRE, FIXATION, INTRAOSSEOUSSYNTHES (USA)DZKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-070

Event Narratives#

D

Patient 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2014 A PROXIMAL FEMORAL NAIL ANTIROTATION WAS USED FOR AN INTERTROCHANTERIC FEMORAL FRACTURE CASE. AFTER SEVERAL CHECKS OF THE DEVICE BY ASSEMBLING WITH NAIL BEFORE IMPLANTATION, THE NAIL WAS INSERTED. AFTER THAT, WHEN THE GUIDE WIRE WAS INSERTED IT THEN INTERFERED WITH THE NAIL. THE SURGEON TRIED TO INSERT THE GUIDE WIRE AGAIN, BUT THE SITUATION DID NOT CHANGE. THE SURGEON REMOVED THE NAIL AND DID SEVERAL DRY CHECKS AGAIN. IT WAS REPORTED THAT THE NAIL WENT INTO THE ERRATIC POSITION AGAINST THE NAIL HOLE. AT THAT POINT, A NEW GUIDE WIRE WAS REPLACED. AFTER THAT, THE OPERATION WAS COMPLETED AS PER THE NORMAL PROCEDURE AND WITHOUT ANY ADDITIONAL PROBLEMS. THERE WAS A FIFTEEN MINUTE SURGICAL DELAY REPORTED. THIS COMPLAINT IS FOR 3 OF 3 COMPLAINT (B)(4).

N

Patient 1

INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.