FDA.reportPublic FDA data

MAUDE MDR 3185075

MDR report key
3185075
Report number
8043862-2013-00004
Event key
0
Event type
3
Date received
2013-06-18
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
MARC SEEGERS
Address
LORENZWEG 5 BERLIN 12099 GM
Phone
930-930-9307
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GUIDE WIREK-WIREAAP IMPLANTATE AGGFC430165QR0001 OR QR0002R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-1801. O

Event Narratives#

D

Patient 1

GUIDE WIRE FOR CANNULATED SCREW BROKE OFF DURING SURGERY. IT BROKE OFF WHEN DOCTOR WAS FLEXING THE JOINT CHECKING TO SEE IF JOINT WAS SECURE. THERE WAS A POP AND THE K-WIRE BROKE. AFTER K-WIRE BROKE DOCTOR TOOK AN X-RAY TO SEE WHERE THE REMAINING PIECE WAS IN THE FOOT. DOCTOR DECIDED TO LEAVE THE PIECE IN THE PT. REMAINING K-WIRE WAS DISCARDED BY SURGEON.

N

Patient 1

IT WAS NOT POSSIBLE FOR THE SALES REP OF OUR DISTRIBUTOR TO RECEIVE A SURGERY REPORT OR ANY X-RAYS FOR EVAL. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO DEVIATION FROM THE SPECIFICATION. THE SALES REP WROTE THAT THE SURGEON DID NOT USE THE OBTURATOR (DRILL GUIDE FOR GUIDE WIRES) AS WRITTEN AND REQUESTED IN THE SURGERY TECHNIQUE. THIS OBTURATOR AVOIDS BENDING FORCES WHICH COULD ARISE WHEN THE GUIDE WIRES TOUCHES THE PERIOST. THEREFORE, IT SEEMS THAT THE BREAKAGE OCCURRED BECAUSE THE USER DID NOT FOLLOW THE INSTRUCTIONS.