AXIAL PIN INSERTER/EXTRACTOR
Received Jan 27, 2020 · Event occurred Dec 19, 2019
Report 3013450937-2020-00007 · MDR key 9633778
Device
Generic name
Prosthesis, Knee
Manufacturer
Onkos SurgicalModel number
25102211ECatalog number
25102211E
Lot number
1488408
Product problems
- Material Deformation
- Insufficient Device Problem Information
- Material Deformation
- Insufficient Device Problem Information
Patient
20 YR
- No Information
- No Clinical Signs, Symptoms or Conditions
- No Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT THE COMPONENT INVOLVED MET SPECIFICATION. THE DAMAGED INSTRUMENT WAS RETURNED FOR FURTHER ANALYSIS AND IT WAS CONFIRMED THAT THE THREADS HAD CROSS THREADED. INTERVIEW WITH THE SALES REPRESENTATIVE FOUND THAT THE SURGEON ATTEMPTED TO KEEP THE INCISION VERY MINIMAL, WHICH DID NOT GRANT THEM EASY TRAJECTORY FOR THE INSTRUMENT. THE SALES REPRESENTATIVE REPORTED THAT THE INSTRUMENT HAD BEEN INSERTED INTO THE PIN ON AN ANGLE, THUS CAUSING THE THREADS TO CROSS AND THE INSTRUMENT TO BECOME DAMAGED. ADDITIONALLY, THIS INSTRUMENT IS REUSABLE, AND ITS LIFE SPAN DEPENDS ON THE METHOD IN WHICH IT IS USED, THE DURATION OF USE, AND ITS HANDLING BETWEEN USES. ULTIMATELY, BASED UPON THE DEVICE HISTORY RECORD AND INTERVIEW WITH THE SALES REPRESENTATIVE IT WAS CONCLUDED THAT THE INSTRUMENT FAILURE COULD NOT BE ATTRIBUTED TO THE MANUFACTURING OF THE ELEOS COMPONENT.
Description of Event or Problem
THE AXIAL PIN INSERTER/EXTRACTOR CROSS THREADED WITH AN AXIAL PIN AND BECAME DAMAGED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND THAT THE COMPONENT INVOLVED MET SPECIFICATION. THE DAMAGED INSTRUMENT WAS REQUESTED TO BE RETURNED FOR FURTHER ANALYSIS. SHOULD ADDITIONAL INFORMATION BE OBTAINED THE REPORT WILL BE SUPPLEMENTED.
Description of Event or Problem
THE AXIAL PIN INSERTER/EXTRACTOR CROSS THREADED WITH AN AXIAL PIN AND BECAME DAMAGED.