SCORPION NEEDLE, KNEE

Additional Manufacturer Narrative

CORRECTED INFORMATION: E1 COUNTRY CORRECTED TO SLOVENIA. ADDITIONAL INFORMATION: G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-12990N WAS RECEIVED INSIDE AN AR-12990 KNEE SCORPION BATCH NUMBER 15333400 FOR INVESTIGATION. THE DEVICE INVESTIGATED WAS THE AR-12990 KNEE SCORPION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED AR-12990 WITH AN AR-12990N, AND IT WAS FOUND THAT THE NEEDLE COULD NOT BE FULLY INSERTED (SEE EVALUATION PICTURE 3). THE AR-12990N WAS MET WITH RESISTANCE AND COULD NOT PASS THROUGH THE SHAFT OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR IN THE DEVICE. EXCESSIVE FORCE WAS USED DURING THE FIRING OF THE NEEDLE, BREAKING THE NEEDLE AND CAUSING A BLOCKAGE WITHIN THE SHAFT. DFU-0392-SUB-EO WARNS AGAINST THE USAGES LISTED TO HELP AVOID NEEDLE BREAKAGE AND POTENTIAL PATIENT INJURY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-12990N WAS RECEIVED INSIDE AN AR-12990 KNEE SCORPION BATCH NUMBER 15333400 FOR INVESTIGATION. THE DEVICE INVESTIGATED WAS THE AR-12990 KNEE SCORPION. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED AR-12990 WITH AN AR-12990N, AND IT WAS FOUND THAT THE NEEDLE COULD NOT BE FULLY INSERTED (SEE EVALUATION PICTURE 3). THE AR-12990N WAS MET WITH RESISTANCE AND COULD NOT PASS THROUGH THE SHAFT OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR IN THE DEVICE. EXCESSIVE FORCE WAS USED DURING THE FIRING OF THE NEEDLE, BREAKING THE NEEDLE AND CAUSING A BLOCKAGE WITHIN THE SHAFT. DFU-0392-SUB-EO WARNS AGAINST THE USAGES LISTED TO HELP AVOID NEEDLE BREAKAGE AND POTENTIAL PATIENT INJURY.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THE INSTRUMENT AR-12990 (LOT: 15333400) WAS USED FOR THE FIRST TIME WITH A NEW AR-12990N NEEDLE, BUT DURING THE OPERATION THE NEEDLE IN THE INSTRUMENT BROKE. ALL FRAGMENTS WERE REMOVED, BUT THE INSTRUMENT DID NOT WORK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 08-DEC-2025 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A MENISCUS SUTURING INSIDE-OUT SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.