inforMED
MalfunctionHTY

UNKNOWN_INSTRUMENTSTIRE_PRODUCT

Received May 20, 2025 · Event occurred Apr 24, 2025

Report 3015967359-2025-01025 · MDR key 22051485

Device

Generic name

Pin, Fixation, Smooth

Catalog number

UNK_ICO

Product problems

  • Fracture
  • Fracture

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER THAT A PIECE OF WIRE WAS FOUND INSIDE THE PIN COLLET. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE; NO DELAY OR ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

D4: UDI IS UNKNOWN AS THE PART/ LOT NUMBER WAS NOT REPORTED. H6: THE QUALITY INVESTIGATION IS COMPLETE.