UNK

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 ROTATOR CUFF SURGERY THE TIP OF THE SCORPION NEEDLE BROKE OFF. LATER, WHILE PLACING THE ANCHOR, THE SURGEON NOTICED THAT THE SMALL TIP WAS LYING NEXT TO THE ANCHOR, INSIDE THE JOINT. NO FRAGMENT REMAINED INSIDE THE PATIENT. WHEN FIRING THE SCORPION, THE SURGEON HAD DELIBERATELY HELD IT AT AN ANGLE TO AVOID HITTING ANY BONES. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THIS LINE WAS CREATED FOR THE SCORPION DEVICE THAT WAS USED WITH THE REPORTED NEEDLE.