inforMED
InjuryHTW

DJO SURGICAL

Received Apr 4, 2025 · Event occurred Dec 31, 2024

Report 1644408-2025-00386 · MDR key 21780956

Device

Generic name

Drill Bit, 3.2x35mm, Bayonet

Catalog number

803-15-008

Lot number

325184L02

Product problems

  • Mechanical Problem
  • Detachment of Device or Device Component
  • Mechanical Problem
  • Detachment of Device or Device Component

Patient

64 YR · Unknown

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions
  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

INSTRUMENT FAILURE - AT TIME OF SURGICAL PREPARATION FOR CANCELLOUS BONE SCREW DURING A TOTAL HIP ARTHROPLASTY PROCEDURE, DURING NORMAL USE OF THE DRILL, THE BIT BROKE OFF WHILE INSIDE THE PATIENT. PER SURGEON, MULTIPLE ATTEMPTS TO REMOVE THE BROKEN DRILL BIT WERE UNSUCCESSFUL. HE JUDGED FURTHER ATTEMPTS TO REMOVE THE RETAINED RILL BIT AS HAVING THE POTENTIAL FOR SIGNIFICANT DAMAGE TO THE BONE AND DECIDED TO PROCEED WITH THE SURGERY, LEAVING THE RETAINED DRILL BIT IN PLACE. THE RECOVERED PORTION OF THE DRILL BIT WAS MEASURED AT 15MM. SURGEON THEN ESTIMATED THE LENGTH OF THE RETAINED PORTION OF THE DRILL BIT AT 20MM. SURGEON ANTICIPATES NO EFFECTS TO PATIENT OF RETAINED PIECE.

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 H4, H10, AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2024-02011; 803-15-006, S303 - BROKE/CRACKED/DAMAGED, INSTRUMENT FAILURE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.