SCANLAN DENNIS RIB CUTTER
Received Dec 13, 2024 · Event occurred Oct 17, 2024
Report 2126670-2024-00007 · MDR key 20925676
Device
Generic name
Rib Cutter
Manufacturer
Scanlan International, Inc.Model number
9909-902Catalog number
9909-902
Lot number
BD6B1
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Prefer Not To Disclose
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RIB CUTTER IN QUESTION WAS NOT RETURNED FOR FURTHER ANALYSIS. REVIEW OF THE DESIGN, MANUFACTURING BATCH RECORD, AND TECHNICAL DOCUMENTATION FOUND NO NON-CONFORMITIES. INSPECTION OF PRODUCT FROM THE CURRENT PRODUCTION LOT INDICATE THAT THE RIB CUTTERS MEET SPECIFICATIONS AND PERFORM AS INTENDED. UNABLE TO DRAW A CONCLUSION FROM THE INFORMATION AVAILABLE.
Description of Event or Problem
THE INSTRUMENT DID NOT CUT THE RIBS BUT CRUSHED THEM INSTEAD. THIS CAUSED AN ESTIMATED ADDITIONAL HOUR DURING THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DID HAVE A GOOD OUTCOME. THIS ISSUE OCCURED WITH THE FIRST USE OF THE INSTRUMENT. AS REPORTED.