SMART TSF WIRE COMBI BOLT

Additional Manufacturer Narrative

THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. THE VISUAL INSPECTION REVEALED ONLY ONE BOLT LONG IS BROKE INTO TWO PIECES. BOTH PIECES WERE RETURNED. THESE DEVICES SHOW SIGNS OF EXTENSIVE WEAR AND USE. THIS INSPECTION WAS CONDUCTED BY NAKED EYE. A FUNCTIONAL EVALUATION PERFORMED ON THE DEVICES REVEALED THE NUTS SEIZED ON THE BOLTS AND CANNOT BE REMOVED. DEVICES BATCH NUMBERS WERE NOT PROVIDED, THUS, AN EVALUATION OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. FOR THE BOLT, A REVIEW OF COMPLAINT HISTORY OF THE PREVIOUS 12 MONTHS REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. FOR THE BOLT LONG AND THE NUT, A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE SURGICAL TECHNIQUE FOR SMART TSF REVEALED THAT IT IS THE RESPONSIBILITY OF TREATING PHYSICIANS TO DETERMINE AND UTILIZE THE APPROPRIATE PRODUCTS AND TECHNIQUES, ACCORDING TO THEIR OWN CLINICAL JUDGMENT, FOR EACH OF THEIR PATIENTS. A REVIEW OF THE RISK MANAGEMENT FILES REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THESE PRODUCTS AND EVENT. FOR THE BOLT, ACCORDING WITH MATERIAL SPECIFICATION, THE QUALITY AND MANUFACTURE FOR STAINLESS STEEL SHALL BE CONTROLLED. FOR THE NUT, ACCORDING WITH THE DRAWING PRINT THE SHARP EDGES SHOULD BE BROKEN. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE USER ERROR, EXCESSIVE FORCES AND/OR PROCEDURAL TECHNIQUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING TSF REMOVAL, NINE (9) SMART TSF WIRE FIXATION BOLTS SNAPPED INTO TWO PARTS WHILE THE SURGEON WAS TRYING TO MOVE WIRES ON THE FOOTPLATE. IT SEEMS THE 10MM NUTS AND THE BOLTS ARE FUSED SOMEHOW. SOME OF THE NUTS BROKE AND WERE DISCARDED. REMOVAL SURGERY WAS COMPLETED AFTER A DELAY GREATER THAN 30 MIN.

Description of Event or Problem

IT WAS REPORTED THAT, DURING TSF REMOVAL, NINE (9) SMART TSF WIRE FIXATION BOLTS SNAPPED INTO TWO PARTS WHILE THE SURGEON WAS TRYING TO MOVE WIRES ON THE FOOTPLATE. IT SEEMS THE 10MM NUTS AND THE BOLTS ARE FUSED SOMEHOW. SINCE THE COMBI BOLT AND NUTS WOULDN¿T COME APART, THEY HAD TO BREAK THE BOLT IN ORDER TO MOVE FORWARD WITH THE PROCEDURE. REMOVAL SURGERY WAS COMPLETED AFTER A DELAY GREATER THAN 30 MIN.