TL PLUS WIRE TENSIONER WITH TIP

Additional Manufacturer Narrative

THE ITEMS PRODUCT CODE 54-1139, LOT1 #: 2008778-10 AND LOT2 #: 1508644-10, MANUFACTURED IN 2020 AND 2015 RESPECTIVELY, WERE RETURNED FOR FURTHER INVESTIGATION, WHICH CONFIRMED THE REPORTED ISSUE. DAMAGE TO THE HEXAGONAL SET SCREW (CODE 39402-0003) WAS OBSERVED, PREVENTING PROPER ADJUSTMENT OF THE EXTENDED TENSIONER TIP. ANALYSIS OF MANUFACTURING RECORDS CONFIRMED THAT THE NOTICED DEVICES WERE RELEASED AS CONFORMING ACCORDING TO SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE EXCLUDED THAT AN INSUFFICIENT CHECK DURING THE REPROCESSING PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. MAINTENANCE, INSPECTION AND FUNCTION TESTING FROM THE RELEVANT INSTRUCTIONS FOR USE PQRMD: THE FAILURE MODES MAY BE CAUSED BY END OF LIFE OF THE PRODUCT, IMPROPER USE OR IMPROPER MAINTENANCE. ORTHOFIX DOES NOT TYPICALLY SPECIFY THE MAXIMUM NUMBER OF USES FOR RE-USEABLE MEDICAL DEVICES. THE USEFUL LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS, INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES. CAREFUL INSPECTION AND FUNCTIONAL TESTING OF THE DEVICE BEFORE USE IS THE BEST WAY TO DETERMINE WHETHER A DEVICE HAS REACHED ITS END OF SERVICEABLE LIFE. ALL INSTRUMENTS AND PRODUCT COMPONENTS MUST BE VISUALLY INSPECTED FOR ANY SIGNS OF DETERIORATION THAT MAY CAUSE FAILURE DURING USE (SUCH AS CRACKS OR DAMAGE TO SURFACES), AND ITS FUNCTIONS MUST BE TESTED BEFORE BEING STERILIZED. IF A COMPONENT OR INSTRUMENT IS BELIEVED TO BE FAULTY, DAMAGED OR SUSPECT, IT MUST NOT BE USED.

Description of Event or Problem

RECEIVED INFORMATION STATING THAT USER EXPERIENCED TENSION ISSUES ON TWO TENSIONERS DURING SURGERY OF A FRACTURED TIBIA. AS PER REPORTER SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE PATIENT IS REPORTED AS BEING IN RECOVERY.

Description of Event or Problem

RECEIVED INFORMATION STATING THAT USER EXPERIENCED TENSION ISSUES ON TWO TENSIONERS DURING SURGERY OF A FRACTURED TIBIA. AS PER REPORTER SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE PATIENT IS REPORTED AS BEING IN RECOVERY.

Additional Manufacturer Narrative

DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR INVESTIGATION, BUT IT HAS BEEN REQUESTED TO RETURN. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE COMPLETED AND A FOLLOW UP REPORT WILL BE SUBMITTED. MAINTENANCE, INSPECTION AND FUNCTION TESTING FROM THE RELEVANT INSTRUCTIONS FOR USE PQRMD: THE FAILURE MODES MAY BE CAUSED BY END OF LIFE OF THE PRODUCT, IMPROPER USE OR IMPROPER MAINTENANCE. ORTHOFIX DOES NOT TYPICALLY SPECIFY THE MAXIMUM NUMBER OF USES FOR RE-USEABLE MEDICAL DEVICES. THE USEFUL LIFE OF THESE DEVICES DEPENDS ON MANY FACTORS, INCLUDING THE METHOD AND DURATION OF EACH USE, AND THE HANDLING BETWEEN USES. CAREFUL INSPECTION AND FUNCTIONAL TESTING OF THE DEVICE BEFORE USE IS THE BEST WAY TO DETERMINE WHETHER A DEVICE HAS REACHED ITS END OF SERVICEABLE LIFE. ALL INSTRUMENTS AND PRODUCT COMPONENTS MUST BE VISUALLY INSPECTED FOR ANY SIGNS OF DETERIORATION THAT MAY CAUSE FAILURE DURING USE (SUCH AS CRACKS OR DAMAGE TO SURFACES), AND ITS FUNCTIONS MUST BE TESTED BEFORE BEING STERILIZED. IF A COMPONENT OR INSTRUMENT IS BELIEVED TO BE FAULTY, DAMAGED OR SUSPECT, IT MUST NOT BE USED.