AEQ. PERFORM+ KEELED PUNCH - SMALL/MEDIUM

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

DURING PRIMARY LEFT ANATOMIC SHOULDER REPLACEMENT, SURGEON WAS PREPARING THE GLENOID SURFACE TO RECEIVE A PERFORM + LEFT SMALL 15DEG POLY IMPLANT. PROCEDURE HAD PROCEEDED WITHOUT INCIDENT, UNTIL THE STEP TO UTILIZE THE KEELED OSTEOTOME AND PUNCH, WHICH ATTACHES ON TO THE HANDLE IN INSTRUMENTS. THE HANDLE WAS FOUND TO BE BROKEN. THE LOCKING SLEEVE WAS COMPLETELY SEPARATE TO THE MAIN HANDLE SHAFT. ATTEMPTS TO REATTACH THE SLEEVE ONTO THE HANDLE SO THE OSTEOTOME / PUNCH CAN BE LOCKED TO THE HANDLE, PROVED FRUITLESS. IN THE END, THE SURGEON FIRST PLACED THE OSTEOTOME (OVER THE GUIDE WIRE STILL INSITU) INTO THE SEMI-PREPARED "KEEL HOLE", THEN PLACED THE HANDLE ON TO THE END OF THE OSTEOTOME, AND IMPACTED THE OSTEOTOME. WITH THE HANDLE NOT ATTACHED TO THE OSTEOTOME, THE ONLY WAY TO REMOVE THE OSTEOTOME, WAS GRABBING IT WITH A PAIR OF HEAVY PLIERS, AND HITTING THE PLIERS WITH A MALLET TO BACK IT OUT. THIS PROCESS WAS REPEATED FOR THE PUNCH. THE SURGEON WAS HAPPY THAT THE KEEL-HOLE WAS ADEQUATELY PREPARED (THE TRIAL IMPLANT SEATED HOME FULLY WHEN INSERTED INTO THE GLENOID), BUT THE SURGEON WAS CONCERNED ABOUT POSSIBLE DAMAGE TO THE GLENOID SURFACE / VAULT, WHEN USING THE MALLET / PLIERS TO REMOVE THE OSTEOTOME / PUNCH.

Additional Manufacturer Narrative

CORRECTION: PLEASE REFER H6 DEVICE CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND PROVIDED IMAGES DOES NOT SHOW KEELED PUNCH. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

DURING PRIMARY LEFT ANATOMIC SHOULDER REPLACEMENT, SURGEON WAS PREPARING THE GLENOID SURFACE TO RECEIVE A PERFORM + LEFT SMALL 15 DEG POLY IMPLANT. PROCEDURE HAD PROCEEDED WITHOUT INCIDENT, UNTIL THE STEP TO UTILIZE THE KEELED OSTEOTOME AND PUNCH, WHICH ATTACHES ON TO THE HANDLE IN INSTRUMENTS. THE HANDLE WAS FOUND TO BE BROKEN. THE LOCKING SLEEVE WAS COMPLETELY SEPARATE TO THE MAIN HANDLE SHAFT. ATTEMPTS TO REATTACH THE SLEEVE ONTO THE HANDLE SO THE OSTEOTOME/PUNCH CAN BE LOCKED TO THE HANDLE, PROVED FRUITLESS. IN THE END, THE SURGEON FIRST PLACED THE OSTEOTOME (OVER THE GUIDE WIRE STILL INSITU) INTO THE SEMI-PREPARED "KEEL HOLE", THEN PLACED THE HANDLE ON TO THE END OF THE OSTEOTOME AND IMPACTED THE OSTEOTOME. WITH THE HANDLE NOT ATTACHED TO THE OSTEOTOME, THE ONLY WAY TO REMOVE THE OSTEOTOME, WAS GRABBING IT WITH A PAIR OF HEAVY PLIERS, AND HITTING THE PLIERS WITH A MALLET TO BACK IT OUT. THIS PROCESS WAS REPEATED FOR THE PUNCH. THE SURGEON WAS HAPPY THAT THE KEEL-HOLE WAS ADEQUATELY PREPARED (THE TRIAL IMPLANT SEATED HOME FULLY WHEN INSERTED INTO THE GLENOID), BUT THE SURGEON WAS CONCERNED ABOUT POSSIBLE DAMAGE TO THE GLENOID SURFACE/VAULT, WHEN USING THE MALLET/PLIERS TO REMOVE THE OSTEOTOME/PUNCH.