STAINLESS STEEL

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A STERNOTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE TIP BROKE OFF AFTER USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. TWO NEEDLES ARE SHOWN IN THE PHOTOS PROVIDED, WAS THERE ANY DEFICIENCY WITH THE SECOND NEEDLE? - DID THE NEEDLE FALL INTO THE PATIENT? IF YES, ¿ WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? ¿ WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? ¿ WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE? ¿ WAS THERE ANY ADDITIONAL TISSUE DAMAGE AS A RESULT OF SEARCHING FOR THE NEEDLE PIECE? ¿ IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE NEEDLE WAS RETAINED? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE IN THE FUTURE? PLEASE PROVIDE DETAILS. ¿ WHAT IS CURRENT CONDITION OF THE PATIENT? H6 INVESTIGATION FINDINGS: C22 - PHOTO REVIEW H3 INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW TWO NEEDLES; ONE OF THEM IS BROKEN INTO TWO SECTIONS AT THE TIP. THE NEEDLE WAS NOTED WITH MARKS THAT APPEARS TO BE BY SURGICAL INSTRUMENT. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.