FDA.reportPublic FDA data

MAUDE MDR 3913202

MDR report key
3913202
Report number
MW5037026
Event key
0
Event type
3
Date of event
2014-06-03
Date received
2014-06-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
110.5 MM FLIP CUTTER IINONEARTHREX INC.HEXFLIP CUTTER IIAR-1204AF-105301539061 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-270

Event Narratives#

D

Patient 1

THE PRODUCT IS A 3.5 MM DRILL THAT HAS A 10.5MM REAMER THAT REMAINS IN LINE WITH THE DRILL UNTIL DEPLOYED. ONCE DEPLOYED, THE DRILL BECOMES A REAMER, 10.5MM, AT ITS TIP. AFTER THIS POSITION DEPLOYED AND ENGAGED THE CORTEX OF THE LATERAL FEMORAL CONDYLE, THE REAMER TIP BROKE INTO SEVERAL PIECES. "I ATTACHED THE PRODUCT BROCHURE FOR A BETTER DESCRIPTION. THIS IS THE SAME TECHNIQUE I'VE USED IN MY APPROXIMATELY 75-100 ACL RECONSTRUCTIONS SINCE STARTING HERE IN (B)(6) 2012".