KNIFE LIGHT 10/PK
Received May 8, 2013 · Event occurred Dec 20, 2012
Report 0008010177-2013-00017 · MDR key 3099733
Device
Generic name
Instrument
Manufacturer
Stryker Osteosynthesis-freiburgCatalog number
3300-001-000
Lot number
11043FE2
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE KNIFELIGHT BROKE AT THE TIP DURING A CASE. THE PIECE WAS RECOVERED AND THE PATIENT WAS NOT HARMED.
Description of Event or Problem
IT WAS REPORTED THAT THE KNIFELIGHT BROKE AT THE TIP DURING A CASE. THE PIECE WAS RECOVERED AND THE PATIENT WAS NOT HARMED.
Additional Manufacturer Narrative
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative
THE VISUAL INVESTIGATION SHOWED THAT PARTS OF THE TRANSPARENT SURROUNDING WERE BROKEN. THE BREAKAGE OF THE TRANSPARENT SURROUNDING WAS CAUSED BY TOO STRONG FORCES IN TERMS OF A BENDING OVERLOAD DURING USE OF THE DEVICE. THERE CORROSION FOUND ON THE WORKING PART OF THE DEVICE AS WELL, WHICH CLEARLY INDICATES THAT THE DEVICE WAS USED. BASED ON THE PERFORMED INVESTIGATION, NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN OR MANUFACTURING RELATED ISSUE.