DJO SURGICAL
Received May 21, 2025 · Event occurred Apr 28, 2025
Report 1644408-2025-00639 · MDR key 22066790
Device
Generic name
Drill Bit, 3.2x35mm, Bayonet
Manufacturer
Encore Medical L.p.Catalog number
803-15-008
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Female
- No Clinical Signs, Symptoms or Conditions
- 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 BITS BROKE WHILE IN USE.
Additional Manufacturer Narrative
SEE H6, H10, AND H11. 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.