FDA Adverse Event Malfunction Summary report: N

ACL TIGHTROPE WITH FIBERTAG

MDR report key: 19441598 · Received May 31, 2024

Report

Report Number: 1220246-2024-04615
Event Type: Malfunction
Date Received: May 31, 2024
Date of Event: March 2, 2022
Report Date: May 31, 2024
Manufacturer: ARTHREX, INC.
Product Code: MBI
PMA / PMN Number: K231857
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE USED DURING SUTURE PASSING/TIGHTENING /TENSIONING.

Description of Event or Problem · 0

ON 03/02/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT A AR-1588RTT TIGHTROPE MALFUNCTIONED. THIS OCCURRED ON (B)(6) 2022 DURING A QUAD ACL RECONSTRUCTION WHEN THE FEMORAL BUTTON ON THE CORTEX WAS FLIPPED AND BEGAN TENSIONING WHITE SUTURES. THEY BEGAN TO ENCOUNTER SOME STRONG RESISTANCE ONE OF THE TENSIONING SUTURES POPPED AT THE LEVEL OF THE BUTTON. THE GRAFT THEN CAME OUT OF THE TUNNEL AND BACK THROUGH THE TIBIA. ANOTHER IMPLANT WAS OPENED AND REPLANTED THE FIBERTAG ONTO THE GRAFT. THEY TRIMMED THE EDGES OF THE FEMORAL SIDE AND IMPLANTED THE GRAFT WITH NO ISSUES. THERE WAS NO PATIENT EFFECT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299709	ACL TIGHTROPE WITH FIBERTAG	SMOOTH FIXATION PIN	MBI	ARTHREX, INC.	ACL TIGHTROPE WITH FIBERTAG	14364719

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown