5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT, "THE SURGEON USED A 5.0 BIOZIP ANCHOR ON THE LEFT SHOULDER FOR A ROTATOR CUFF SUPRASPINATUS TEAR. THE SUTURE (FORCE FIBER) BROKE. THE SURGEON BACKED OUT THE ANCHOR USING THE ORIGINAL TROCAR TIP INSERTER. HE THEN WENT IN WITH A 6.5 BIOZIP. WHEN HE WAS TYING HIS KNOTS ARTHROSCOPICALLY, THE ANCHOR EYELETS BROKE. HE THEN BACKED OUT OF 6.5. HE TRIED TO USE AN "ARTHRY" BIOCOCK SCREW AND IT PULLED OUT. SO HE DID A MINI-OPEN PROCEDURE AND INSERT ANOTHER BIOCOCKSCREW."

Additional Manufacturer Narrative

ADDITIONAL INFO WILL BE PROVIDED, ONCE INVESTIGATION IS COMPLETED.