DJO SURGICAL
Received Jul 16, 2025 · Event occurred Jun 18, 2025
Report 1644408-2025-01059 · MDR key 22527196
Device
Generic name
Drill Bit, 3.2x35mm, Bayonet
Manufacturer
Encore Medical L.p.Catalog number
803-15-008
Lot number
UNKNOWN
Product problems
- Mechanical Problem
- Detachment of Device or Device Component
- Mechanical Problem
- Detachment of Device or Device Component
Patient
NA · Female
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
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
INSTRUMENT FAILURE - DRILL BIT BROKE, BROKEN FRAGMENTED PIECES LEFT IN THE PATIENT.
Additional Manufacturer Narrative
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2024-00442; 803-15-008, 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.