FDA.reportPublic FDA data

MAUDE MDR 9908157

MDR report key
9908157
Report number
1643264-2020-00187
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-31
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
1MOTOR DRIVE UNIT HAND CNTRL PWRMX ELSAW, POWERED, AND ACCESSORIESSMITH & NEPHEW, INC.HAB7220061672200616R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE MOTOR DRIVE UNIT WAS NOT WORKING. THERE WAS A BACKUP DEVICE AVAILABLE. A DELAY GREATER THAN THIRTY MINUTES WAS REPORTED. NO PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.