REPROCESSED SUTURE RETRIEVER
Received Jun 14, 2017 · Event occurred May 10, 2017
Report 3032391-2017-00015 · MDR key 6641475
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. IT CANNOT BE CONFIRMED THAT THE DEVICE WAS REPROCESSED. HOWEVER, THE LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THE REPORTED ISSUE WAS COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED. THE USER FACILITY CONFIRMED THAT THE TIP WAS RETRIEVED FROM THE PATIENT AT THE TIME OF THE PROCEDURE; GENERAL ANESTHESIA WAS USED; HOWEVER THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE AT THIS TIME, HOWEVER IF MORE INFORMATION IS PROVIDED THEN THIS REPORT WILL BE UPDATED. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE OR ADDITIONAL MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.
Description of Event or Problem
WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED DEPUY MITEK EXPRESSEW¿ SUTURE NEEDLE DETACHED DURING USE. THE TIP WAS LOCATED AND RETRIEVED FROM THE PATIENT BY THE SURGEON.