MULTIFIRE SCORPION NEEDLE (BLACK) OR (DARK GREY)

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT DURING A ROTATOR CUFF SURGERY. PER REPORT, A 1MM PIECE/DEVICE FRAGMENT WAS OBSERVED ON THE X-RAY TAKEN ON THE PATIENTS SHOULDER. THE DOCTOR REPORTEDLY FELT COMFORTABLE TO LEAVE THE DEVICE FRAGMENT INSIDE OF THE PATIENT. ANOTHER DEVICE WAS OBTAINED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR AN ADVERSE PATIENT EVENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH REPORT. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. IT CANNOT BE CONFIRMED IF THE DEVICE IS A REPROCESSED DEVICE. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT DURING A ROTATOR CUFF SURGERY.

Additional Manufacturer Narrative

UPDATED CONCOMITANT MEDICAL PRODUCTS, PMA/510K, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MFR. THE REPORTING FACILITY RETURNED THE REPROCESSED MULTIFIRE SCORPION NEEDLE. THE MEDLINE RENEWAL PACKAGING AND LABEL WERE NOT RECEIVED WITH THE DEVICE. UPON INSPECTION OF THE RETUNED DEVICE, IT WAS OBSERVED THAT THE TIP OF THE DEVICE HAD BROKEN OFF. THE REPORTED COMPLAINT IS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. PER THE ORIGINAL EQUIPMENT MANUFACTURER'S INSTRUCTIONS-FOR-USE, THE TIP OF THE SCORPION NEEDLE MAY BREAK IF EXCESSIVE FORCE IS APPLIED. USE OF EXCESS FORCE TO PASS THE NEEDLE THROUGH FIBROUS/CALCIFIED TISSUE, OR STRIKING A BONE, CAN CAUSE NEEDLE BREAKAGE AND PATIENT INJURY. TO AVOID THIS, REPOSITION THE NEEDLE TO PASS THROUGH A DIFFERENT AREA. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.