ST. WIRE PASS STEEL BUR,MED
Received May 2, 2012 · Event occurred Apr 3, 2012
Report 1017294-2012-00023 · MDR key 2556793
Device
Product problems
- Break
Patient
37 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO BURS FROM THE SAME LOT, USED DURING THE SAME PROCEDURE, BROKE OFF AT THE DISTAL TIP IN THE PATIENT'S TOE (BILATERALLY). MR. (B)(6) ALSO WROTE IN THE MEDWATCH FORM WHICH HE SUBMITTED; "PER THE SURGEON, THE BODIES WERE RETAINED DUE TO THE FACT THAT THEY COULD NOT BE RETRIEVED WITHOUT SIGNIFICANT DAMAGE TO THE BONE. THE OBJECTS ARE NOT EXPECTED TO MIGRATE, OR CAUSE FUTURE PROBLEMS FOR THE PATIENT."
Additional Manufacturer Narrative
AS OF TODAY (5/2/2012), THE TWO BURS IN QUESTION HAVE NOT BEEN RETURNED TO CONMED LINVATEC. THREE VOICE MAIL MESSAGES HAVE BEEN LEFT FOR (MR. (B)(6)), WITH NO RESPONSE AS TO THE RELEASE OF THE BURS TO CONMED LINVATEC. WITHOUT A PROPER EVALUATION, THE ALLEGED BUR BREAKAGE CANNOT BE CONFIRMED, AND ROOT CAUSE CANNOT BE DETERMINED. THE REMAINDER OF THE BURS HAVE BEEN RETAINED BY THE USER FACILITY. THERE ARE NO OTHER COMPLAINTS FOR THIS ITEM AND LOT NUMBER COMBINATION. THE LOT IS SIZE 75 UNITS, AND NO NONCONFORMING PRODUCT REPORT (NCR) WAS CREATED DURING THE MANUFACTURING OF THIS DEVICE. (B)(4). THIS FAILURE MODE IS ADDRESSED IN THE RISK DOCUMENT, AND THE SAFETY RISK IS JUSTIFIABLE (AS LOW AS REASONABLY POSSIBLE). IF THE PRODUCTS ARE RELEASED AND RECEIVED, AN EVALUATION WILL BE CONDUCTED AND THE COMPLAINT WILL BE PROCESSED ACCORDINGLY. PRODUCTS HAVE NOT BEEN RETURNED.