DRILL (STAINLESS STEEL)
Received Apr 24, 2019 · Event occurred Mar 26, 2019
Report 2027467-2019-00020 · MDR key 8544876
Device
Product problems
- Break
- Detachment of Device or Device Component
Patient
71 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT TWO ASPIDA DRILLS WERE UTILIZED DURING THE CASE, ONE OF WHICH BROKE. BOTH INSTRUMENTS ARE OF THE SAME PRODUCT PART NUMBER/DESCRIPTION BUT CONTAIN A SEPARATE IDENTIFYING LOT NUMBERS. IT IS UNKNOWN WHICH MANUFACTURING LOT NUMBER BELONGS TO THE FRACTURED INSTRUMENT. LOT: 7325601, MANUFACTURED 8/21/2014; LOT: 6232206, MANUFACTURED: 3/7/2011. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH INSTRUMENTS REVEALED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. THE INSTRUMENTS WERE FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH DESIGN SPECIFICATIONS. NO EVALUATION POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO OBTAIN THE INSTRUMENT HAVE BEEN UNSUCCESSFUL. UPON THE RECEIPT OF ADDITIONAL INFORMATION AND/OR THE PRODUCT IN QUESTION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
AN ASPIDA DRILL BIT BROKE OFF IN THE PATIENT WHILE CREATING A PILOT HOLE. THE DETACHED SECTION REMAINS POSITIONED WITHIN THE ANTERIOR WALL OF THE L5 VERTEBRAL BODY.
Additional Manufacturer Narrative
AN EVALUATION BOTH RETURNED INSTRUMENT FOUND THAT MANUFACTURING LOT# 7325601 REPRESENTS THE FRACTURED INSTRUMENT. THE DETACHED SECTION WHICH REMAINS WITHIN THE PATIENTS ANTERIOR WALL OF THE L5 VERTEBRAL BODY, IS APPROXIMATELY .870" IN LENGTH AND MANUFACTURED FROM 465SS WHICH COMPLIES WITH ASTM STANDARDS. ADDITIONAL INSPECTION UNDER MAGNIFICATION FOUND THAT THE INSTRUMENT APPEARS TO HAVE FAILED DUE TO EXCESSIVE LATERAL BENDING AND NOT A TWISTING MOTION THAT WOULD BE EXPECTED WITH THE USE OF THIS DEVICE.