SUBTALAR CBS SYS 7.5 C SINK CANN AO 80MM
Received Dec 1, 2014 · Event occurred Nov 12, 2014
Report 9613350-2014-04162 · MDR key 4308607
Device
Generic name
Burr, Orthopedic
Manufacturer
Normed Medizin-technik GmbhModel number
NACatalog number
503004350
Lot number
UNK
Product problems
- Corroded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE KIT INSPECTION RUST WAS DETECTED ON A SUBTALAR CBS SYS 7.5 SINK CANN AO 80MM ON (B)(6) 2014 AFTER RETURN OF THE HOSPITALS. IT WAS ALSO REPORTED THAT THERE WAS ALREADY A BLACK SHINE ON THE INSTRUMENTS AT THE OPERATION.
Additional Manufacturer Narrative
THE MFR RECEIVED THE DEVICE FOR INVESTIGATION ON NOVEMBER 20 2014. THE INVESTIGATION IS PENDING. PICTURES OF THE DEVICE WERE RECEIVED FOR REVIEW. AS THE LOT NUMBER OF THE INSTRUMENT IS UNREADABLE DUE TO RUST, IT IS NOT POSSIBLE TO CHECK THE DHR AT THE MOMENT. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MED DEVICE REPORT WILL BE SUBMITTED. (B)(4).