APTUS
Received Mar 12, 2026 · Event occurred Dec 8, 2025
Report 3003236702-2026-00004 · MDR key 24579563
Device
Generic name
1.6 K-wire, 60mm, Olive 10mm, 1/pkg
Manufacturer
Medartis AgCatalog number
A-5045.41/1
Lot number
67446521
Product problems
- Break
Patient
60 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE OLIVE WIRE CAN BREAK IN THE SHAFT DURING INSERTION/REMOVING: WHEN THE WIRE SHAFT IS PRE DAMAGED DURING SURGERY. WHEN THE WIRE IS BLOCKED IN THE TIP AREA DURING INSERTION/REMOVING. WHEN FURTHER TORQUE IS APPLIED WHEN THE OLIVE HAS CONTACT WITH AN IMPLANT. BY EXCESSIVE BENDING OF THE SHAFT DURING INSERTION/REMOVING. COMBINATIONS OF THE REASONS ABOVE. VISUAL INSPECTION OF THE THREE PARTS OF THE WIRE SHOWS: THE OLIVE WIRE IS FRACTURED IN TWO PARTS DUE TO MECHANICAL OVERLOAD (FORCE FRACTURE). SEVERAL DAMAGE OF THE SHAFT OF THE WIRE. PLASTIC DEFORMATION OF THE TIP OF THE WIRE. ACCORDING TO MISSING MARKS ON THE OLIVE THE OLIVE HAD PROBABLY NO CONTACT TO AN IMPLANT. THE INVESTIGATION LEADS TO THE ASSUMPTION THAT THE OLIVE WIRE BROKE DUE TO MECHANICAL OVERLOAD (FORCE FRACTURE). HOW AND WHY THIS OVERLOAD OCCURRED CANNOT BE DETERMINED.
Description of Event or Problem
THE TIP OF THE K-WIRE BROKE DURING REMOVAL FROM THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. NO HARM OCCURRED TO THE PATIENT.
Additional Manufacturer Narrative
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE PROVIDED.
Description of Event or Problem
THE TIP OF THE K-WIRE BROKE DURING REMOVAL FROM THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. NO HARM OCCURRED TO THE PATIENT.