FDA Adverse Event Malfunction Summary report: N

1.8 MM Q-FIX SOFT SUTURE ANCHOR

MDR report key: 3998014 · Received July 10, 2014

Report

Report Number: 3006524618-2014-00197
Event Type: Malfunction
Date Received: July 10, 2014
Date of Event: June 5, 2014
Report Date: January 26, 2016
Manufacturer: ARTHROCARE CORPORATION
Product Code: MBI
PMA / PMN Number: K133727
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. THE MOST PLAUSIBLE ROOT CAUSE IS THAT THE USER DID NOT FOLLOW THE IFU PROVIDED WITH THE DEVICE. THE IFU STATES, "DO NOT IMPLANT THE ANCHOR IN POOR QUALITY BONE OR WHERE BONE QUANTITY IS LIMITED. INCOMPLETE INSERTION OR POOR BONE QUALITY MAY RESULT IN IMPLANT PULLOUT OR SUTURE BREAKAGE." REVIEW OF MANUFACTURING RECORDS FOR THE LOT FOUND NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A 1.8MM Q-FIX SOFT SUTURE ANCHOR, AFTER THE ANCHOR WAS INSERTED THE SUTURES PULLED OUT OF ANCHOR UPON TIGHTENING. A NEW ANCHOR WAS PLACED IN THE SAME BONE HOLE, HOWEVER YIELDED THE SAME RESULTS WHEN TIGHTENED. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
405545	1.8 MM Q-FIX SOFT SUTURE ANCHOR	FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE	MBI	ARTHROCARE CORPORATION		1068270

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR