COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE
Received Mar 24, 2023 · Event occurred Mar 2, 2023
Report 0008010177-2023-00015 · MDR key 16610244
Device
Generic name
Instrument
Manufacturer
Stryker Leibinger FreiburgModel number
N103ACatalog number
N103A
Lot number
22203047
Product problems
- Fracture
- Fracture
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UPDATE: THE REPORTED EVENT COULD BE NOT CONFIRMED, BECAUSE OF THE DEVICE HAS NOT BEEN RETURNED. H3 OTHER TEXT: DISCARDED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THE NEEDLE BROKE OFF INTO THE PATIENT AND THE TIP COULD NOT BE LOCATED DUE TO SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THE NEEDLE BROKE OFF INTO THE PATIENT AND THE TIP COULD NOT BE LOCATED DUE TO SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED.