DJO SURGICAL
Received Apr 4, 2025 · Event occurred Feb 4, 2025
Report 1644408-2025-00399 · MDR key 21780952
Device
Generic name
Drill Bit, 4.0mm, Calibrated, Graduated Depth Marks
Manufacturer
Encore Medical L.p.Catalog number
804-03-049
Lot number
UNKNOWN
Product problems
- Mechanical Problem
- Detachment of Device or Device Component
- Mechanical Problem
- Detachment of Device or Device Component
Patient
79 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 - INSTRUMENT BROKE FROM WEAR, BROKEN/FRAGMENTED PIECES LEFT IN THE PATIENT.
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
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2024-00422; 804-03-049, S303 - BROKE/CRACKED/DAMAGED, INSTRUMENT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.