AXLE INTERSPINOUS FUSION SYSTEM

Additional Manufacturer Narrative

A VISUAL ASSESSMENT OF THE RETURNED SYSTEM INSERTER/COMPRESSOR SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY WORN LASER MARKINGS AND SURFACE SCRATCHES. THE DISTAL LIP OF THE INSTRUMENT WAS FRACTURED AND NOT PRESENT. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED INSTRUMENT, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE INSTRUMENT LOT WHICH MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 6/14/2019. IT MAY BE POSSIBLE FOR THE OBSERVED INSTRUMENT MALFUNCTION TO OCCUR IF EXCESSIVE FORCE WAS PLACED ON THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT TO THE INSERTER/COMPRESSOR. THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT IS INTENDED TO BE TIGHTENED TO SECURELY RETAIN THE IMPLANT. IF FORCE IS APPLIED BEYOND WHAT IS REQUIRED TO SECURELY RETAIN THE IMPLANT, IT MAY RESULT IN THE DISTAL LIP OF THE INSTRUMENT TO MALFUNCTION AS OBSERVED. BASED ON THE INFORMATION REVIEWED, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE AN UNINTENDED USER ERROR RELATED TO EXCESSIVE FORCE PLACED ON THE SET SCREW THAT ENGAGES AND RETAINS THE SYSTEM IMPLANT. THERE HAS BEEN ONE OTHER COMPLAINT OF SIMILAR NATURE FOR THIS INSTRUMENT IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMPLAINTS OF SYSTEM INSERTER/COMPRESSORS WITH BROKEN DISTAL LIPS.

Description of Event or Problem

IT WAS REPORTED THAT THE DISTAL IMPLANT GRASPING PORTION OF A SYSTEM INSERTER/COMPRESSOR WAS BROKEN WHILE ENGAGING A SYSTEM IMPLANT. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. A RETURN AUTHORIZATION NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH WAS RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.