CAPIO

Additional Manufacturer Narrative

BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF APRIL 8,2026 WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF SERVICE. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BULLET DART DETACHMENT. BLOCK H11: THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS COULD BE PERFORMED. AS A RESULT, THE REPORTED DEVICE PERFORMANCE ALLEGATION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF "DART DETACHMENT OF DEVICE OR DEVICE COMPONENT" WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED DUE TO A LACK OF EVIDENCE, AND IN THE ABSENCE OF DEVICE EVALUATION OR OBJECTIVE EVIDENCE, THE MOST PROBABLE CAUSES THAT MAY HAVE CONTRIBUTED TO THE EVENT REMAIN UNKNOWN; THEREFORE, THIS COMPLAINT IS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF "CAUSE NOT ESTABLISHED", AS THE INVESTIGATION FINDINGS DO NOT CLEARLY CONFIRM THE PRESENCE OR ABSENCE OF THE REPORTED PROBLEM WITH THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE BULLET DETACHED FROM THE SUTURE ON TWO SEPARATE MONODEK SUTURES. INITIALLY, THE BULLET WAS THOUGHT TO BE LODGED IN THE PELVIS; HOWEVER, IT WAS LATER DETERMINED TO BE RETAINED WITHIN THE CHANNEL ON THE CAPTURE SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE PROCEDURE.