ARH SOLUTIONS 2 HEAD 22MM, RIGHT

Additional Manufacturer Narrative

MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE RETURNED 9.0MM X 0.0MM STEM (PART NUMBER TR-S0900-S, BATCH 575300) AND THE ARH SOLUTIONS 2 HEAD 22MM, RIGHT (PART NUMBER 5001-0522R-S, BATCH 597343) WERE EXAMINED VISUALLY UNDER MAGNIFICATION. THE HEAD AND STEM WERE RETURNED ASSEMBLED. THE ALIGNMENT GUIDANCE LASER MARKS ON THE HEAD AND STEM WERE IN-LINE AS ASSEMBLED. THE TEXTURED-GRIT SURFACE OF THE STEM EXHIBITED SPORADIC WEAR AT VARIOUS LOCATIONS; INSTEAD OF HAVING A MATTE/GRIT TEXTURE IN THESE LOCATIONS, SMOOTH/BARE/SHINY UNDERLYING METAL WAS SEEN. THERE WAS LIGHT WEAR ON THE HEAD PORTION; A SCRATCH WAS PRESENT ALONG/INSIDE THE CONCAVE PORTION OF THE HEAD. AS THE STEM'S QUALITY-MEASURED FORM IS WITHIN SPECIFICATION, IT IS LESS LIKELY THAT THE ENGAGEMENT BETWEEN THE RETURNED STEM'S INSERTABLE GRIT-BLASTED LENGTH AND THE REAMED RADIAL CANAL FAILED DUE TO THE STEM'S GEOMETRY. GIVEN THAT THE STEM WAS PROPERLY SIZED, POTENTIAL ISSUES THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE OF THE RADIUS COULD INVOLVE TOPICS SUCH AS USER TECHNIQUE, PATIENT-SPECIFIC ANATOMICAL CONCERNS, RADIAL CANAL PREPARATION, SIZING OF THE RADIAL CANAL AS REAMED, AND/OR INSERTION METHOD / INSERTION TOOLS USED. IT IS NOT POSSIBLE TO CONCLUSIVELY DISCUSS OTHER PART-BASED ASPECTS OF THE ENGAGEMENT FAILURE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE IN-FIELD EVENT, AS NO OTHER PARTS WERE RETURNED (READ: THE REAMER WAS NOT RETURNED AND CANNOT BE EVALUATED). IT WAS POSSIBLE THAT THE WEAR TO THE TEXTURIZED STEM COULD HAVE OCCURRED DUE TO REMOVAL OF THE DEVICE FROM THE RADIUS IF TOOLS WERE USED TO ASSIST IN REMOVING THE IMPLANT. IT IS UNCLEAR HOW OR WHY THE CONCAVE FEATURE OF THE HEAD IS WORN / SCRATCHED, AS THE PROPER IN-KIT TOOL (HEAD IMPACTOR) FOR INSERTING THE HEAD-STEM IMPLANT ASSEMBLY INTO THE REAMED RADIAL CANAL HAS A SOFT, RUBBERIZED BLACK DELRIN TIP THAT SHOULD NOT SCRATCH OR OTHERWISE CAUSE WEAR TO THE HEAD OF THE IMPLANT IN THIS REGION. HOWEVER, BASED ON THE INFORMATION RECEIVED AND DUE TO UNKNOWN SURGICAL CONDITIONS, THE ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED DURING SURGERY AFTER COMPLETELY REAMING THE CORRECT STEM SIZE WITH NO ISSUES, THE SURGEON BEGAN TO INSERT THE RADIAL HEAD AND STEM IMPLANT WHEN THE RADIUS SPLIT. WE WERE UNABLE TO SEPARATE THE STEM AND HEAD, SO THEY WERE REMOVED. A SMALLER STEM WAS USED WITH CEMENT TO FIX THE CRACKED RADIUS WITH NO CERCLAGE SUTURE. THE SURGERY WAS COMPLETED WITH NO DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2024-005867 FOR THE STEM INVOLVED IN THIS EVENT.