UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Dec 2, 2024 · Event occurred Nov 11, 2024
Report 3015967359-2024-02369 · MDR key 20820310
Device
Generic name
Pin, Fixation, Smooth
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_ICO
Lot number
UNKNOWN
Product problems
- Material Disintegration
- Material Disintegration
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: FULL UDI IS NOT AVAILABLE DUE TO MISSING CATALOG AND LOT NUMBER. H6: THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
NO NEW INFORMATION.
Additional Manufacturer Narrative
D4: UDI IS UNKNOWN AS THE LOT/PART NUMBER WAS NOT REPORTED. H6: A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, METAL FRAGMENTS CAME FROM THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.