DRILL, 2.5MM X 127MM
Received Jul 11, 2024 · Event occurred Jun 10, 2024
Report 1644408-2024-01036 · MDR key 19726881
Device
Product problems
- Material Deformation
- Material Integrity Problem
- Material Deformation
- Material Integrity Problem
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Description of Event or Problem
INTRUMENT FAILURE - BROKEN INSTRUMENT LEFT IN PATIENT.
Additional Manufacturer Narrative
THE AGENT REPORTED "WE HAVE HAD A NEAR MISS TODAY WITH A NEVER EVENT AT SWLEOC WITH MR PATEL. THE GLENOID DRILL BIT SNAPPED OFF DURING GLENOID PREPARATION, IT IS STAYING IN THE PATIENT AS IMPOSSIBLE TO RETRIEVE. IT IS FORTUNATELY DEEMED NOT A NEVER EVENT AS THEY KNOW WHERE ITS LOCATED WITHIN THE PATIENT." THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. SIGNIFICANT ADVERSE EVENT WAS REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED. THE INSTRUMENTS WAS INSPECTED PRIOR TO USE. THE AGENT WAS PRESENT DURING THIS EVENT AND WAS ABLE TO PROVIDE ANOTHER SUITABLE DEVICE. THE REPORTED DEVICE WAS NOT RETURNED TO SURGICAL FOR EVALUATION. THE PRODUCT FEEDBACK FORM INDICATES THE DEVICE WAS LEFT IN THE PATIENT. IF THE DEVICE IS RETURNED AT A LATER TIME AN AMENDMENT WILL BE OPENED. A REVIEW OF THE INSTRUMENT'S DEVICE HISTORY RECORDS (DHR) REVEALED, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NCMRS ASSOCIATED WITH THE PRODUCTION OF THE INSTRUMENT THAT IS RELATED TO THE REPORTED ISSUE. THE IMPLANT LOT NUMBER WAS NOT REPORTED THUS COULD NOT BE LINKED TO A DHR FOR REVIEW. COMPLAINT DATABASE REVIEW 1 SHOWED PREVIOUS COMPLAINT BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. S303 - BROKE/CRACKED/DAMAGED, 1. 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. THE ROOT CAUSE OF THIS COMPLAINT IS DIFFICULT TO DETERMINE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT IS LIKELY ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION, OR ISSUE.