DRILL, 2.5MM X 127MM
Received May 9, 2024 · Event occurred Apr 9, 2024
Report 1644408-2024-00637 · MDR key 19282941
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
80 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THERE WAS A 1 HOUR DELAY IN SURGERY.
Additional Manufacturer Narrative
ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.
Additional Manufacturer Narrative
SEE D4 EXPIRATION DATE, D10, H4 AND H11. THE AGENT REPORTED (BROKEN DRILL BIT DR.(B)(6) DRILLED THE PILOT HOLE THROUGH THE DRILL SLEEVE, EXTRACTED THE DRILL BIT AND THE TIP DID NOT COME OUT. HE FELT NO POP, ONLY LOOKED AT THE BIT AND NOTICED IT MISSING. THERE WAS NOTHING I OBSERVED, OR DR RAMSEY INDICATED HAPPENED TO CAUSE IT TO BREAK.) THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THE SURGERY WAS COMPLETED AS INTENDED, WITH A ONE-HOUR DELAY. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND WAS DEEMED ACCEPTABLE FOR USE BASED ON ITS APPEARANCE. THE AGENT WAS PRESENT DURING SURGERY AND WAS ABLE TO SOURCE A SUITABLE REPLACEMENT DEVICE. THE DEVICE WAS USED DURING SURGERY. RMA EXAMINATION: THE INSTRUMENT WAS NOT RETURNED TO DJO AND AFTER FURTHER EXAMINATION, A LOCKING BONE SCREW IMPLANT WAS RECEIVED WHICH IS NOT THE FACTOR OF THIS COMPLAINT. IF THE INSTRUMENT IS RETURNED AT A LATER DATE, AN AMENDMENT WILL BE OPENED TO DOCUMENT ANY NEW INFORMATION. THE REVISION LEVEL OR LOT NUMBER WERE NOT REPORTED; THEREFORE, THIS INSTRUMENT COULD NOT BE LINKED TO A SPECIFIC DEVICE HISTORY RECORD (DHR) OR THE ACTUAL DATE OF MANUFACTURE COULD NOT BE DETERMINED WITH CONFIDENCE. COMPLAINT DATABASE REVIEW SHOWED ONE PREVIOUS COMPLAINT BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. S303 - BROKE/CRACKED/DAMAGED. S302 - BENT, 1. 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.