UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Dec 11, 2024 · Event occurred Nov 15, 2024
Report 3015967359-2024-02399 · MDR key 20910006
Device
Generic name
Pin, Fixation, Smooth
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
UNK_ICO
Lot number
UNKNOWN
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 TESTING BY THE CUSTOMER, A BROKEN PIN WAS FOUND INSIDE THE ATTACHMENT. 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 CATALOG/LOT NUMBER WAS NOT REPORTED. H6: A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
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.