FDA.reportPublic FDA data

MAUDE MDR 9896891

MDR report key
9896891
Report number
1643264-2020-00182
Event key
0
Event type
3
Date of event
2019-12-20
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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.HAB7220061672200616* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING AN ACL SURGERY THE MDU WAS NOT ROTATING, IT WAS STUCK. THE PROCEDURE WAS CANCELLED AND THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.