AXLE INTERSPINOUS FUSION SYSTEM

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF A PRODUCT COMPLAINT ON 03/25/2025. A SYSTEM INSERTER/COMPRESSOR WAS RETURNED TO THE MANUFACTURER COUPLED WITH ANOTHER SYSTEM INSERTER COMPLAINT. UPON RECEIPT OF THIS INSERTER, IT WAS NOTED THAT THE STOP OF THE DISTAL TIP WAS DAMAGED. COMMUNICATIONS WITH THE COMPLAINANT CONFIRMED THIS INSTRUMENT WAS POSSIBLY UTILIZED DURING PROCEDURE, HOWEVER, THE COMPLAINANT WAS UNAWARE OF DAMAGE AT THE DISTAL TIP. IT IS UNCLEAR AS TO WHEN THE DAMAGE TO THE DISTAL TIP OCCURRED. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION AVAILABLE.

Additional Manufacturer Narrative

A VISUAL ASSESSMENT OF THE RETURNED SYSTEM INSERTER/COMPRESSOR SHOWED AN INSTRUMENT WITH REPEATED USE, AS IDENTIFIED BY SURFACE SCRATCHES. ONE OF THE STOPS ON THE DISTAL TIP OF THE INSTRUMENT WERE FRACTURED FROM THE BODY OF THE SYSTEM INSERTER/COMPRESSOR. A FUNCTIONALITY ASSESSMENT WAS NOT PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED SYSTEM INSERTER/COMPRESSOR, WHICH WAS REMOVED FROM DISTRIBUTABLE INVENTORY. A DHR REVIEW WAS PERFORMED FOR THE INSTRUMENT LOT AND THERE WAS NO MANUFACTURING ANOMALIES IDENTIFIED. THE INSTRUMENT LOT MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 10/10/2024. THE COMPLAINANT WAS UNAWARE OF THE DAMAGED DISTAL TIP AND COULD NOT CONFIRM WHEN THE DAMAGE OCCURRED. THE ROOT CAUSE OF THE DAMAGED DISTAL TIP IS UNABLE TO BE RELIABLY DETERMINED, BUT COULD BE RELATED TO THE IMPACTS TO THE SYSTEM INSERTER/COMPRESSOR. THERE HAS BEEN ONE OTHER COMPLAINT OF SIMILAR NATURE IN THE PAST 12 MONTHS. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS INSTRUMENT FOR COMPLAINTS FROM THE FIELD.