FDA.reportPublic FDA data

MAUDE MDR 9894923

MDR report key
9894923
Report number
1219602-2020-00560
Event key
0
Event type
3
Date of event
2019-12-12
Date received
2020-03-28
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
1TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BLFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUESMITH & NEPHEW, INC.MBI72202595722025952025331R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-280

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR SURGERY, THE ANCHOR SLIPPED OUT AND IT CAN'T SCREW-IN. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACKUP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT UNIT THREADS WERE DAMAGED (BURNISHED AND SCALLOPED) WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.