FDA.reportPublic FDA data

MAUDE MDR 9857469

MDR report key
9857469
Report number
1643264-2020-00156
Event key
0
Event type
3
Date of event
2020-02-20
Date received
2020-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
HOLLY TOPPING
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MOT DR UNIT HNDCONT POWERMAX ELITESAW, POWERED, AND ACCESSORIESSMITH & NEPHEW, INC.HAB7220087272200872* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-190

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE MDU WAS OVERHEATING. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.