UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Jun 6, 2025 · Event occurred May 5, 2025
Report 3015967359-2025-01090 · MDR key 22161785
Device
Generic name
Pin, Fixation, Smooth
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_ICO
Product problems
- Fracture
- No Apparent Adverse Event
- Fracture
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: FULL UDI NOT PROVIDED AS DEVICE AND LOT IS UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT A K-WIRE BROKE INSIDE OF THE DRIVER DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES REPORTED.
Description of Event or Problem
THE INITIAL REPORTER HAS INDICATED THAT THE COMPLAINT FOR THE UNKNOWN PIN IS NOT REGARDING A STRYKER DEVICE.
Additional Manufacturer Narrative
THE INITIAL REPORTER HAS INDICATED THAT THE COMPLAINT FOR THE UNKNOWN PIN IS NOT REGARDING A STRYKER DEVICE. H6: THE QUALITY INVESTIGATION IS COMPLETE.