DJO SURGICAL

Additional Manufacturer Narrative

ONCE THE INVESTIGATION IS COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE GLENOID PIN BROKE DURING CENTRAL HOLE REAMING ON HARD BONE. APPROXIMATELY 2 INCHES OF THE PIN REMAINED INSIDE THE PATIENT AND COULD NOT BE RETRIEVED.

Additional Manufacturer Narrative

SEE D4, H4, H6, H10 AND H11 FOR ADDITIONAL INFORMATION: THE AGENT REPORTED "THE GLENOID PIN WAS PLACED REAMING ON HARD BONE. DURING THE CENTRAL HOLE REAMING THE DRILL PIN BROKE OF THE GLENOID. ABOUT 2 INCHES OF THE PIN WAS LEFT INSIDE OF THE PATIENT. THE BROKEN PIN WAS UNABLE TO BE RETRIEVED." THIS EVENT OCCURRED DURING SURGERY NEAR THE PATIENT. HEALTHCARE PROFESSIONAL INDICATED SERIOUS RISK TO THE PATIENT. A 60 MIN. DELAY IN SURGERY WAS NOTED. WHEN THIS EVENT OCCURRED, THERE WAS NOT ANOTHER SUITABLE DEVICE AVAILABLE, AND THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND ACCEPTABLE. RMA EXAMINATION: THE REPORTED INSTRUMENT WAS LOST/DISCARDED (SEE ATTACHED FORM) THEREFORE THE EVENT CANNOT BE CONFIRMED. SURGICAL INSTRUMENTS CONDITION CAN BE DETERMINED WHILE BEING USED FOR ITS INTENDED PURPOSE. THE REPLACEMENT OF SURGICAL INSTRUMENTS DUE TO NORMAL WEAR AND TEAR DOES NOT INDICATE PRODUCT DEFICIENCY, FAILURE OR ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORDS (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED AND THE ITEM WAS LOST/DISCARDED. THE ROOT CAUSE OF THIS COMPLAINT WAS THE DRILL PIN BROKE OFF, LIKELY DUE TO PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS AN EVENT ASSOCIATED WITH USAGE, NOT AN EVENT ASSOCIATED WITH PRODUCT FAILURE, MALFUNCTION, OR ISSUE. CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE(S) SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT NEED A REVIEW. THERE ARE NO INDICATIONS THAT THE INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. THEREFORE, NO CONTAINMENT OF INVENTORY IS REQUIRED. EVENT IS ASSOCIATED WITH INSTRUMENT USAGE, NOT A DESIGN OR MANUFACTURING ISSUE.