COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5

Additional Manufacturer Narrative

THE REPORTED EVENT THAT A COUNTERSINK, CANNULATED AUTOFIX 2.0/2.5 BROKE DURING SURGERY COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE MOST LIKELY CAUSE IS THAT THE INTEGRITY OF THE INSTRUMENT HAD NOT BEEN VERIFIED PRIOR TO USE. THE COUNTERSINK HAD EXPERIENCED EXCESSIVE USE OR FORCE IN PREVIOUS SURGERIES, ITS TIP GOT DAMAGED/WORN AND THUS BECAME SUSCEPTIBLE TO BREAKAGE. THE DEVICE INSPECTION REVEALED THAT THE DEVICE DOES NOT PRESENT ANY SIGNS OF RUST OR DISCOLORATION. THE TIP RESULTS BROKEN AND SHOWS A HELICAL FRACTURE. FATIGUE ZONES CAN BE OBSERVED ON THE BREAKAGE SURFACES. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE INSTRUCTION FOR USE (V15138 REV B SYSTEME AUTOFIX NON STERILE LBL 0898) WAS REVIEWED: EXAMINE INSTRUMENTS FOR WEAR OR DAMAGE BEFORE USE. WHILE RARE, INTRA-OPERATIVE INSTRUMENT BREAKAGE MAY OCCUR. INSTRUMENTS THAT HAVE EXPERIENCED EXCESSIVE USE OR FORCE MAY BE SUSCEPTIBLE TO BREAKAGE. INTRA-OPERATIVE SAFETY PRECAUTIONS PRIOR TO USE, VERIFY THE INTEGRITY OF THE IMPLANTS AND INSTRUMENTS. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

Description of Event or Problem

OPERATING ROOM MANAGER REPORTED THE FOLLOWING EVENT, DURING A PROCEDURE, THE DEVICE FRACTURED AND A METAL FRAGMENT WAS LEFT INSIDE THE PATIENT'S BONE. THE CONTACT PERSON CALLED AND THE PROCEDURE WAS STILL ONGOING. THE SURGEON WAS TRYING TO EXTRACT/ REMOVE THE FRAGMENT FROM THE PATIENT. UPDATE RECEIVED FROM CUSTOMER ON SEPT 22ND STATED THE WAS DEVICE USED FOR A CARPAL SCAPHOID NONUNION SCREWING. THE EVENT HAPPENED WHEN PREPARING THE LOCATION OF THE SCREW HEAD BY HAND AND WITHOUT FORCE. RUPTURE OF A TOOTH OF THE CUTTER WITHIN THE SCAPHOID. THE FRAGMENT WAS NOT POSSIBLE TO RETRIEVE. DELAY OF 10 MINUTES.

Additional Manufacturer Narrative

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

Description of Event or Problem

OR MANAGER REPORTED THE FOLLOWING EVENT, DURING A PROCEDURE, THE DEVICE FRACTURED AND A METAL FRAGMENT WAS LEFT INSIDE THE PATIENTS' BONE. THE CONTACT PERSON CALLED AND THE PROCEDURE WAS STILL ONGOING. THE SURGEON WAS TRYING TO EXTRACT/ REMOVE THE FRAGMENT FROM THE PATIENT. UPDATE RECEIVED FROM CUSTOMER ON (B)(6) STATED THE WAS DEVICE USED FOR A CARPAL SCAPHOID NONUNION SCREWING. THE EVENT HAPPENED WHEN PREPARING THE LOCATION OF THE SCREW HEAD BY HAND AND WITHOUT FORCE. RUPTURE OF A TOOTH OF THE CUTTER WITHIN THE SCAPHOID. THE FRAGMENT WAS NOT POSSIBLE TO RETRIEVE. DELAY OF 10 MINUTES.