FDA.reportPublic FDA data

MAUDE MDR 3105065

MDR report key
3105065
Report number
8030965-2013-02179
Event key
0
Event type
3
Date received
2013-05-10
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
ADAM SHUKUR
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TROCAR ?4 GREENSYNTHES GMBHKTE356.8332118381Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-05-100

Event Narratives#

D

Patient 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE DISTAL SCREW REPEATEDLY MISSED THE NAIL. THIS CAUSED A SIGNIFICANT DELAY OF THE OR TIME, GREATER THAN 20 PERCENT. THE SURGEON CHANGED THE AIMING ARM FOR DYNAMIC LOCKING, AND THE SCREW COULD THEN BE INSERTED. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

N

Patient 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

N

Patient 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE REVIEW OF THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE INSTRUMENT WAS MANUFACTURED TO THE SPECIFICATIONS. A FUNCTIONAL TEST HAS SHOWN THAT THE INSTRUMENT FUNCTIONS PROPERLY. THE REVIEW WITH FUNCTION GAGES AND TEST MANDEL SHOWED NO DEVIATIONS. THE COMPLAINED FAILURE COULD NOT BE REPRODUCED. PLACEHOLDER.