FDA.reportPublic FDA data

MAUDE MDR 812972

MDR report key
812972
Report number
MW1041882
Event key
0
Event type
3
Date of event
2006-11-02
Date received
2007-02-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORTHO - LOCKEXTRACTION PINSTRYKERHXY3X110CM**NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-02-060

Event Narratives#

D

Patient 1

WHILE WORKING ON PT'S RIGHT KNEE, DURING BILATERAL TOTAL KNEE REPLACEMENTS, THE ORTHO LOCK EXTRACTION PIN BROKE OFF LEAVING APPROX 2CM OF THE PIN IN THE PT'S RIGHT TIBIA. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE BROKEN PORTION AND HE NOTIFIED THE PT OF THE INCIDENT.