FDA.reportPublic FDA data

MAUDE MDR 8471537

MDR report key
8471537
Report number
3004086872-2019-00001
Event key
0
Event type
3
Date of event
2019-01-16
Date received
2019-04-01
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
MR. TRAVIS CANNEFAX
Address
867 W 400 N LOGAN UT 84321 US
Phone
435-435-4357
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHAMPION SUTURE PASSER NEEDLESUTURE PASSER NEEDLECOORSTEK MEDICALGAB3910-900-0913910-900-0911304213Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-010

Event Narratives#

N

Patient 1

REVIEW OF THE DEVICE HISTORY RECORD SHOWS THERE WERE NO NON-CONFORMANCE ASSOCIATED WITH THIS MANUFACTURE LOT. THE SAMPLE NEEDLES TESTED IN THIS LOT SHOWED WITH 95% CONFIDENCE THAT 99% OF THE MANUFACTURE LOT WOULD MEET OR EXCEED THE MINIMUM 24 CYCLE REQUIREMENT. SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE ALLEGED PROBLEM INDICATES REPEATED USE, SO IT IS POSSIBLE THE NEEDLES WERE USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE. COUNTRY OF EVENT: (B)(6).

D

Patient 1

MR (B)(6) FROM THE HOSPITAL REPORTED TO THE ANSM: "AFTER EACH END OF INTERVENTION, CHECK THE INTEGRITY OF THE CHAMPION NEEDLE IN THE CLAMP. NEEDLE THAT WAS NO LONGER INTACT BECAUSE IT WAS BROKEN ON 3.4 MM. PIECE NOT FOUND. CLINICAL CONSEQUENCES NOTED: NEED TO INFORM THE PATIENT WHO WILL BE ANXIOUS. A PRIORI NO CLINICAL CONSEQUENCES TO BE EXPECTED APART FROM A RATHER RARE MIGRATION. DEFECTIVE NEEDLE QUARANTINED FOR EXPERTISE. RADIO ON (B)(6) 2019 WITH OBSERVATION OF THE TIP OF THE NEEDLE IN A TRANS TENDONOUS SITUATION".