FDA.reportPublic FDA data

MAUDE MDR 9908309

MDR report key
9908309
Report number
1219602-2020-00576
Event key
0
Event type
3
Date of event
2020-03-10
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
1FAST-FIX 360 CURVED NDL DELIVERY SYSSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENESMITH & NEPHEW, INC.GAT722024687220246850791959R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, THE FAST FIX'S T1 WAS DEPLOYED, BUT T2 COULDN'T BE DEPLOYED. T1 AND T2 WERE LEFT SECURED TO THE MENISCUS ROOT PART. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THERE WAS A DELAY OF UNDER 30 MIN REPORTED AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.