DRILL BIT FOR PLATES 2.0MM
Received Jul 14, 2015 · Event occurred Jun 12, 2015
Report 3032391-2015-00004 · MDR key 4925922
Device
Generic name
2.0mm Drill Bit
Manufacturer
Medline RenewalModel number
DC6106Catalog number
N/A
Lot number
225466
Product problems
- Break
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE TIP HAD BROKEN OFF AND WAS MISSING. A ROOT CAUSE OF THE DEVICE BREAKAGE HAS NOT BEEN DETERMINED. PRIOR TO RELEASE OF THIS DEVICE, MULTIPLE MICROSCOPIC INSPECTIONS WERE PERFORMED TO CONFIRM ITS INTEGRITY. A REVIEW OF THE PROCESS CONTROL DOCUMENTATION FOR THIS LOT WAS REVIEWED. THIS DEVICE WAS FOUND TO MEET ALL PROCESS SPECIFICATIONS AND WAS APPROVED AND RELEASED FOR AN ADDITIONAL SINGLE USE.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF A DRILL BIT BROKE OFF IN A BONE DURING A LAPIDUS BUNIONECTOMY PROCEDURE ON (B)(6) 2015. WE WERE INFORMED THAT THE SURGEON CHOSE TO LEAVE THE BROKEN PORTION OF THE DRILL BIT IN THE BONE IN PLACE OF ONE OF THE INTENDED SCREWS. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED AND NO SURGICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS INCIDENT. THE ISSUE WAS IDENTIFIED WHEN THE MATERIALS MANAGER INVENTORIED THE USED SCREWS AND FOUND THAT ONLY FOUR WERE USED INSTEAD OF THE SURGEON'S STANDARD USE OF FIVE SCREWS. NO DEVICE PACKAGING WAS SAVED AS THE SURGEON DID NOT DETERMINE THIS INCIDENT TO BE AN ISSUE AT THE TIME OF THE PROCEDURE.