MAUDE MDR 516400

MDR report key
516400
Report number
1934422-2004-00001
Event key
0
Event type
3
Date received
2004-03-02
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#

Address
500 EAST 6TH STREET VINTON IA 52349 US
Phone
319-319-3194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FROG LEGSNANAKNONANANANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-03-020

Event Narratives#

D

Patient 1

FROG LEGS, MANUFACTURED BY FROG LEGS, INC., ARE A SPECIALIZED TYPE OF SHOCK ABSORBING FRONT CASTER ASSEMBLY FOR A WHEELCHAIR. FROG LEGS ARE ATTACHED TO A TILITE ZRA WHEELCHAIR USING A STEM BOLT. BECAUSE THE FRONT CASTERS ON A WHEELCHAIR ARE SUBJECT TO HIGH STRESSES IN DAILY WHEELCHAIR USE, THE SPECIFICATIONS FOR THE STEM BOLT CALL FOR IT TO BE MANUFACTURED FROM 4140 STEEL. THIS TYPE OF STEEL IS SPECIFIED BECAUSE OF ITS HIGH TENSILE STRENGTH AND ELASTICITY IN ORDER TO ENSURE THAT IT WILL BEND BUT NOT BREAK UNDER HIGH STRESS. TISPORT, LLC AND FROG LEGS, INC. HAVE DETERMINED THAT THE SUPPLIER WHO MANUFACTURED THE STEM BOLTS DID NOT MFR THEM TO THE SPECIFICATIONS GIVEN TO SUCH MFR BY FROG LEGS, INC. SPECIFICALLY, THE MFR WAS SUPPOSED TO USE 4140 STEEL BUT MISTAKENLY USED 1144 STRESSPROOF STEEL, WHICH IS LESS ELASTIC THAN 4140 STEEL. AS A RESULT OF THE IMPROPER MFR OF THE STEM BOLTS, THE STEM BOLTS BROKE ON THE FROG LEGS ON THE WHEELCHAIR MANUFACTURED FOR THE PT. FROG LEGS, INC. HAS NOTIFIED ALL PURCHASERS OF TILITE ZRA WHEELCHAIRS WITH FROG LEGS THAT THE STEM BOLTS COULD BREAK AND IS IN THE PROCESS OF OBTAINING REPLACEMENT STEM BOLTS MADE TO THE CORRECT SPECIFICATIONS. TILITE HAS CEASED ALL SHIPMENTS OF NEW TILITE ZRA PRODUCTS WITH FROG LEGS UNTIL IT RECEIVES THE NEW STEM BOLTS.