FDA.reportPublic FDA data

MAUDE MDR 9662544

MDR report key
9662544
Report number
1219602-2020-00162
Event key
0
Event type
3
Date of event
2020-01-09
Date received
2020-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1ARTHROPIERCE INSTRUMENT CURVED LEFTACCESSORIES,ARTHROSCOPICSMITH & NEPHEW, INC.NBH722011867220118650514117R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-030

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING SURGERY THE ARTHROPIERCE BROKE. IT IS UNKNOWN IF THERE WAS ANY BACKUP DEVICE AVAILABLE; THEREFORE, IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY, PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.