TUFFIER RIB SPREADER SCORED

Description of Event or Problem

IT WAS REPORTED THAT THE RETRACTOR/TUFFIER RIB SPREADER SCORED) BROKE DURING OPEN DECORTICATION OF RIGHT LUNG. "THE KNOB THAT ALLOWS FOR THE OPENING OF THE RETRACTOR BROKE OFF. THE RETRACTOR WAS IMMEDIATELY REMOVED. ALL THE PIECES WERE RETRIEVED. THE SURGEON HAD TO CUT A PIECE OF RIB OFF IN ORDER TO SEQUESTER ALL THE PIECES. ONCE THE PIECES WERE RETRIEVED, THE DEVICE WAS PLACED OFF THE STERILE FIELD AND BAGGED." IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DELAY IN PROCEDURE DUE TO THE PRODUCT PROBLEM. A DIFFERENT RETRACTOR WAS USED TO COMPLETE THE CASE. AN X-RAY WAS REPORTEDLY PERFORMED IN THE INTENSIVE CARE UNIT (ICU), AS THE PIECE BROKE OFF CLEANLY."

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

UPDATED FIELD -D9, G3, G6, H2, H3, H6, H11. 300150 TUFFIER RIB SPREADER SCRD WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE EVALUATION OF THE RETURNED 300150 RIB SPREADER IS IN USED CONDITION WITH DAMAGE AND RUST ALONG THE SURFACE. THE LOT NUMBER WAS NOT VISIBLE ON THE PRODUCT, INDICATING A MANUFACTURE DATE PRIOR TO 2018 OR SIGNIFICANT WEAR TO THE ETCHING. THE HANDLE WAS BROKEN OFF AND THE SCREW IT ATTACHED TO WAS DEFORMED BY FORCE. THE INSIDE OF THE HANDLE WAS RUSTED. BREAKAGE MAY HAVE BEEN THE RESULT OF CORROSION TO THE DEVICE DUE TO WEAR, LEADING TO DIFFICULTY TURNING THE HANDLE. DIFFICULTY TURNING THE HANDLE MAY HAVE LED THE USER TO APPLY EXCESSIVE FORCE, CAUSING DEFORMATION AND BREAKAGE OF THE SCREW. THE LOT NUMBER WAS NOT AVAILABLE FOR DHR REVIEW. ROOT CAUSE - THE REPORTED COMPLAINT IS CONFIRMED. THE DAMAGES AND RUST ALONG THE SURFACE MAY BE THE RESULT OF WEAR OVER SEVERAL YEARS OF USE. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED.

Additional Manufacturer Narrative

UPDATED FIELDS: G3, G6, H2, H11. ADDITIONAL FIELD: H6 (INVESTIGATION FINDINGS 1). CORRECTED FIELDS: H1 (CORRECTED FROM FOLLOW-UP 1).