BROACH, PEGGED GLENOID

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-9233, BROACH, WAS RECEIVED FOR INVESTIGATION. VISUAL INVESTIGATION NOTED THAT THE DEVICE HAD SIGNIFICANT SURFACE DAMAGE ALONG THE BODY. THE LASER MARKS WERE FADED; THERE WERE STRIKE MARKS ON THE HANDLE AND THE EDGES WERE DULL. FUNCTIONAL TESTING NOTED SOME RESISTANCE WHEN MOVING THE DEVICE UP AND DOWN. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO A COMBINATION OF NORMAL WEAR-AND-TEAR FROM REPEATED USE AND INSUFFICIENT CLEANING/REPROCESSING, RESULTING IN THE BUILDUP OF RESIDUE AND BIOBURDEN INSIDE THE INSTRUMENT. THIS COMBINATION CAN RESTRICT INTERNAL MOVEMENT AND CAUSE THE DEVICE TO BECOME ¿SLUDGY,¿ STICKY, AND UNABLE TO FUNCTION PROPERLY. THE COMPLAINT ALLEGATION IS CONFIRMED. REFER TO THE INVESTIGATION PHOTOS.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Description of Event or Problem

ON 12/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9233 BROACH SEIZED UP INTERNALLY DURING USE. NO CASE INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP ON 12/8/25. THE DEVICE WAS "SLUDGY AND STICKY" WITH NO WAY TO CLEAN THE BIO BURDEN. THE ISSUE WAS DISCOVERED AFTER A TOTAL SHOULDER ARTHROPLASTY WITH NO PATIENT HARM.