SLENDER INSERTER

Description of Event or Problem

IT WAS REPORTED THAT THE SLENDER INSERTER WAS FOUND BENT AT THE FRONT, SPECIFICALLY THE PART IN CONTACT WITH BONE, DURING SURGERY WHEN AN IMPLANT WAS INSERTED. THE BENDING WAS SUSPECTED TO HAVE OCCURRED DURING A PREVIOUS SURGERY AND WAS ATTRIBUTED TO A POSSIBLE DESIGN CHALLENGE, AS THE INNER PART WITH A STOP CAN DEFORM WHEN MEETING BONE FROM THE VERTEBRAL BODY ABOVE OR BELOW THE DISC. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL MANUFACTURER NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: D9. CORRECTED (G3) ALERT DATE. THE CORRECT ALERT DATE FOR THIS COMPLAINT IS (2/13/26) FEB. 13, 2026 BASED ON AEI NOTE A-14956832. H3, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE SHAFT OF THE INNER PIN STOPPER WAS SLIGHTLY BENT. FURTHERMORE THE OTHER MATING COMPONENTS WERE NOT RETURNED FOR EVALUATION. IT'S WORTH MENTIONING THAT THE LOT NUMBER WAS UNABLE TO BE RETRIEVED DUE TO THIS CONDITION. THE OBSERVED DAMAGE/BENT CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. ACCORDING TO THE CONDUIT¿ CERVICAL SYSTEM INSTRUMENTS THE SLENDER INSERT IT'S THE FOLLOWING: -CONNECT THE TUBE WHEEL (PART 2) TO THE DISTAL END OF THE OUTER TUBE (PART 1). -INSERT THE GRIPPER (PART 3) INTO THE PROXIMAL END OF THE OUTER TUBE WHILE HOLDING BOTH THE OUTER TUBE AND THE TUBE WHEEL FIRMLY IN PLACE. -INSERT THE GRIPPER (PART 3) INTO THE PROXIMAL END OF THE OUTER TUBE WHILE HOLDING BOTH THE OUTER TUBE AND THE TUBE WHEEL FIRMLY IN PLACE. -ENGAGE THE THREADS OF THE TUBE WHEEL ONTO THE THREADS OF THE GRIPPER BY TURNING THE TUBE WHEEL ONE FULL TURN CLOCKWISE TO HOLD THE PIECES LOOSELY TOGETHER. -ATTACH THE TAIL WHEEL (PART 4) TO THE DISTAL END OF THE TUBE WHEEL. HOLD IN PLACE WHILE COMPLETING THE NEXT STEP. -SLIDE THE DISTAL END OF THE PIN WITH STOPS (PART 5) INTO THE PROXIMAL END OF THE GRIPPER. ALIGN THE FORKS OF THE PROXIMAL END OF THE PIN WITH THE EDGES OF THE GRIPPER. -SLIDE THE FORKS OF THE PIN PAST THE TIP OF THE GRIPPER UNTIL THE PIN CAN¿T GO ANY FURTHER. ENGAGE THE THREADS OF THE TAIL WHEEL WITH THE THREADS OF THE PIN BY TURNING THE TAIL WHEEL ONE FULL TURN CLOCKWISE. -ALTERNATIVELY, YOU MAY USE THE NON-STOP PIN IN PLACE OF THE PIN WITH STOPS TO COMPLETE THIS STEP. -TURN THE TAIL WHEEL TO CHANGE THE POSITION OF THE PIN. FOR THE MISSING COMPONENTS CONDITION, THIS CONDITION MAY OCCUR DURING THE CLEANING/STERILIZATION PROCESS, PARTICULARLY WHEN THE COMPONENTS ARE ASSEMBLED OR DISASSEMBLED. AS THESE PROCEDURES ARE OFTEN REPEATED, THERE IS AN INCREASED RISK OF COMPONENTS GOING MISSING. HOWEVER, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE SLENDER INSERTER WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT ==> A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.