SUTURE UNKNOWN

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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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: DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? COULD YOU PLEASE PROVIDE THE PROCEDURE(S) NAME? WHICH TISSUE WAS BEING SUTURED WHEN THE ISSUE OCCURRED? DID THE SUTURE THREAD BREAK, DID THE NEEDLE BREAK, OR DID BOTH COULD YOU PLEASE PROVIDE THE LOT NUMBER AND PRODUCT CODE? WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE IMPLEMENTED TO RETRIEVE THE BROKEN PIECE? WAS THERE ANY ADDITIONAL TISSUE DAMAGE RESULTING FROM THE SEARCH FOR THE NEEDLE PIECE? DOES A FRAGMENT OF THE NEEDLE REMAIN IN THE PATIENT¿S TISSUE? IF SO, IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? IF SO, COULD YOU PLEASE PROVIDE THE SCHEDULED DATE FOR THE REMOVAL? IN WHICH TISSUE STRUCTURE WAS THE BROKEN NEEDLE LOCATED? WHAT IS THE SURGEON¿S OPINION OF THE POTENTIAL CONSEQUENCES FOR THE PATIENT? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? WHAT IS THE TOTAL NUMBER OF PROCEDURES? HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, COULD YOU PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? IF THIS EVENT OCCURRED DURING MULTIPLE PROCEDURES, WOULD YOU KINDLY CREATE A PRODUCT COMPLAINT FOR EACH EVENT AND PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE HCP HAD A NUMBER OF EMAILS IN THE PAST WEEK TO COMPLAIN ABOUT THESE SUTURES. THE NEEDLES ARE SNAPPING AND LEAVING HALF IN THE HEAD OF A PATIENT, SUTURE SNAPPING AND NEEDING TO OPEN ANOTHER PACK. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.