FDA.reportPublic FDA data

MAUDE MDR 9772681

MDR report key
9772681
Report number
1219602-2020-00446
Event key
0
Event type
3
Date of event
2020-02-06
Date received
2020-03-01
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
1SET MENISCUS MENDER II DISPOSABLEPASSERSMITH & NEPHEW, INC.HWQ720948572094852031439R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-010

Event Narratives#

N

Patient 1

(B)(6).

D

Patient 1

IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A SCREW BROKE WHILE BEING TAPPED. IT IS UNKNOWN WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A BACK-UP SCREW WENT IN AND HELD, BUT THE SURGERY WAS DELAYED MORE THAN 30 MIN. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.